Verifying Accurate Leading-edge IVCT Development Act of 2023 or the VALID Act of 2023
This bill requires the Food and Drug Administration (FDA) to regulate in vitro clinical tests (IVCTs).
Currently, the FDA and the Centers for Medicare & Medicaid Services have authority to regulate in vitro diagnostic devices. The bill defines IVCTs, which includes in vitro diagnostic devices, as tests intended for the collection, preparation, analysis, or in vitro clinical examination of specimens from the human body to provide information about a disease, condition, or treatment.
An IVCT may not be introduced into interstate commerce unless it has received FDA premarket approval or is covered by certain exemptions, such as an exemption for a test that (1) was developed and introduced before this bill's enactment and meets certain requirements, (2) is a low-risk test, (3) is solely for public health surveillance, (4) is covered by a technology certification issued under this bill, or (5) has received a humanitarian exemption or emergency use authorization.
The FDA may grant upon application a technology certification. Generally, such a certification covers a group of tests that use a single technology and may be evaluated using a representative test. While such a certification is valid, a qualifying IVCT that falls within the scope of the certification shall be cleared for interstate commerce.
The bill also imposes various requirements related to IVCTs, including those related to quality control, labeling, and reporting adverse events.
The FDA shall have various enforcement authority, including authority to order the recall of an IVCT with a reasonable probability of causing serious adverse health consequences.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2369 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 2369
To amend the Federal Food, Drug, and Cosmetic Act with respect to in
vitro clinical tests, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 29, 2023
Mr. Bucshon (for himself and Ms. DeGette) introduced the following
bill; which was referred to the Committee on Energy and Commerce, and
in addition to the Committee on Ways and Means, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to in
vitro clinical tests, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
(a) Short Title.--This Act may be cited as the ``Verifying Accurate
Leading-edge IVCT Development Act of 2023'' or the ``VALID Act of
2023''.
SEC. 2. DEFINITIONS.
(a) In General.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended--
(1) by adding at the end the following:
``(ss)(1) The term `in vitro clinical test' means an article
specified in subparagraph (2) that is intended to be used in the
collection, preparation, analysis, or in vitro clinical examination of
specimens taken or derived from the human body for the purpose of--
``(A) identifying or diagnosing a disease or condition;
``(B) providing information for diagnosing, screening,
measuring, detecting, predicting, prognosing, analyzing, or
monitoring a disease or condition, including by making a
determination of an individual's state of health; or
``(C) selecting, monitoring, or informing therapy or
treatment for a disease or condition.
``(2) An article specified in this subparagraph is--
``(A) a test kit;
``(B) a test system;
``(C) a test protocol or laboratory test protocol;
``(D) an instrument (as defined in section 587(11));
``(E) a specimen receptacle (as defined in section
587(17));
``(F) software, excluding software that is excluded by
section 520(o) from the definition of a device under section
201(h), that--
``(i) is a component or part of another in vitro
clinical test or analyzes, processes, or interprets a
signal or pattern from another in vitro clinical test;
and
``(ii) does not analyze, process, or interpret a
signal, pattern, or medical image from a device; and
``(G) subject to subparagraph (3), a component or part of a
test kit, a test system, a test protocol or laboratory test
protocol, an instrument, a specimen receptacle, or software
described in subparagraph (F), whether alone or in combination,
including reagents, calibrators, and controls.
``(3) Notwithstanding subparagraph (2)(G), an article intended to
be used as a component or part of an in vitro clinical test described
in subparagraph (1) is excluded from the definition in subparagraph (1)
if the article consists of any of the following:
``(A) Blood, blood components, or human cells or tissues,
from the time of acquisition, donation, or recovery of such
article, including determination of donor eligibility, as
applicable, until such time as the article is released as a
component or part of an in vitro clinical test by the
establishment that collected such article.
``(B) An article used for invasive sampling, a needle, or a
lancet, except to the extent such article, needle, or lancet is
an integral component of an article for holding, storing, or
transporting a specimen.
``(C) General purpose laboratory equipment.'';
(2) by adding at the end of paragraph (g) the following:
``(3) The term `drug' does not include an in vitro clinical
test.''; and
(3) in paragraph (h)(1), in the matter following clause
(C), by striking ``section 520(o)'' and inserting ``section
520(o) or an in vitro clinical test''.
(b) Exclusion From Definition of Biological Product.--Section
351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is
amended--
(1) by striking ``(1) The term `biological product' means''
and inserting ``(1)(A) The term `biological product' means'';
and
(2) by adding at the end the following:
``(B) The term `biological product' does not include an in
vitro clinical test as defined in section 201(ss) of the
Federal Food, Drug, and Cosmetic Act.''.
(c) In Vitro Clinical Test Definition.--In this Act, the term ``in
vitro clinical test'' has the meaning given such term in section
201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a).
SEC. 3. REGULATION OF IN VITRO CLINICAL TESTS.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is
amended--
(1) by amending the heading of chapter V to read as
follows: ``DRUGS, DEVICES, AND IN VITRO CLINICAL TESTS''; and
(2) by adding at the end of chapter V the following:
``Subchapter J--In Vitro Clinical Tests
``SEC. 587. DEFINITIONS.
``In this subchapter:
``(1) Analytical validity.--The term `analytical validity'
means, with respect to an in vitro clinical test, the ability
of the in vitro clinical test, to identify, measure, detect,
calculate, or analyze (or assist in such identification,
measurement, detection, calculation, or analysis of) one or
more analytes, biomarkers, substances, or other targets
intended to be identified, measured, detected, calculated, or
analyzed by the test.
``(2) Applicable standard.--The term `applicable standard',
with respect to an in vitro clinical test, means a reasonable
assurance of analytical and clinical validity for its
indications for use, and a reasonable assurance of safety for
individuals who come into contact with such in vitro clinical
test, except that such term, with respect to specimen
receptacles and test instruments, means a reasonable assurance
of analytical validity for its indications for use and safety
for individuals who come into contact with such specimen
receptacle or test instrument.
``(3) Clinical use.--The term `clinical use' means the
operation, application, or functioning of an in vitro clinical
test for the purpose for which it is intended as described in
section 201(ss)(1).
``(4) Clinical validity.--The term `clinical validity'
means the ability of an in vitro clinical test to achieve the
purpose for which it is intended as described in section
201(ss)(1).
``(5) Component or part.--The term `component or part'
means a substance, piece, part, raw material, software,
firmware, labeling, or assembly, including reagents, that is
intended to be included as an aspect of an in vitro clinical
test described in section 201(ss)(1).
``(6) Develop.--The term `develop', with respect to an in
vitro clinical test, means--
``(A) designing, validating, producing,
manufacturing, remanufacturing, labeling, advertising,
propagating, importing, or assembling an in vitro
clinical test;
``(B) modifying an in vitro clinical test,
including modifying the indications for use of the in
vitro clinical test, or modifying an article to be an
in vitro clinical test; or
``(C) establishing a test system as described or
included in a test protocol developed by another entity
unless such test protocol is listed as an in vitro
clinical test in the comprehensive test information
system established under section 587T by that other
entity.
``(7) Developer.--The term `developer' means a person who
engages in development as described in paragraph (6), except
the term does not include a laboratory that--
``(A) is certified by the Secretary under section
353 of the Public Health Service Act; and
``(B) assembles for use solely within that
laboratory, without otherwise developing, an in vitro
clinical test appropriately listed in the comprehensive
test information system established under section 587T
by a different person.
``(8) First-of-a-kind.--The term `first-of-a-kind', with
respect to an in vitro clinical test, means that such test has
any novel combination of the elements specified in paragraph
(10) that differs from in vitro clinical tests that already are
legally available in the United States, except for such tests
offered under section 587C(a)(3), 587C(a)(4), or 587G.
``(9) High-risk.--The term `high-risk', with respect to an
in vitro clinical test or category of in vitro clinical tests,
means that an undetected inaccurate result from such test, or
such category of tests, when used as intended--
``(A)(i) is reasonably likely to result in serious
or irreversible harm or death to a patient or patients,
or would otherwise cause serious harm to the public
health; or
``(ii) is reasonably likely to result in the
absence, significant delay, or discontinuation of life-
supporting or life-sustaining medical treatment; and
``(B) mitigating measures are not able to be
established and applied to prevent, mitigate, or detect
the inaccurate result, or otherwise sufficiently
mitigate the risk resulting from an undetected
inaccurate result described in subparagraph (A), such
that the test would be moderate-risk or low-risk.
``(10) Indications for use.--The term `indications for
use', with respect to an in vitro clinical test, means the
following elements:
``(A) Substance or substances measured by the in
vitro clinical test, such as an analyte, protein, or
pathogen.
``(B) Test method.
``(C) Test purpose or purposes, as described in
section 201(ss)(1).
``(D) Diseases or conditions for which the in vitro
clinical test is intended for use, including intended
patient populations.
``(E) Context of use, such as in a clinical
laboratory, in a health care facility, prescription
home use, over-the-counter use, or direct-to-consumer
testing.
``(11) Instrument.--
``(A) In general.--The term `instrument' means an
analytical or pre-analytical instrument.
``(B) Analytic instrument.--The term `analytic
instrument' means an in vitro clinical test that is
hardware intended by the developer to be used with one
or more other in vitro clinical tests to generate a
clinical test result, including software used to
effectuate the functionality of the hardware.
``(C) Pre-analytical instrument.--The term `pre-
analytical instrument' means an in vitro clinical test
that is hardware intended by the developer solely to
generate an output for use exclusively with one or more
analytical instruments as defined in subparagraph (B)
and which does not itself generate a clinical test
result. Such term may include software used to
effectuate the hardware's functionality.
``(12) Instrument family.--The term `instrument family'
means more than one instrument developed by the same developer
for which the developer demonstrates and documents, with
respect to all such instruments, that all--
``(A) have the same basic architecture, design, and
performance characteristics;
``(B) have the same indications for use and
capabilities;
``(C) share the same measurement principles,
detection methods, and reaction conditions, as
applicable; and
``(D) produce the same or similar analytical
results from samples of the same specimen type or
types.
``(13) Laboratory operations.--The term `laboratory
operations'--
``(A) means the conduct of a laboratory examination
or other laboratory procedure on materials derived from
the human body, including the conduct of an in vitro
clinical test and associated activities, that is--
``(i) regulated under section 353 of the
Public Health Service Act; and
``(ii) not related to the design,
analytical validation, or clinical validation
of an in vitro clinical test; and
``(B) includes--
``(i) performing pre-analytical and post-
analytical processes for an in vitro clinical
test;
``(ii) standard operating procedures and
the conduct thereof; and
``(iii) preparing reagents or other test
materials that do not meet the criteria for
being an in vitro clinical test for clinical
use.
``(14) Low-risk.--The term `low-risk', with respect to an
in vitro clinical test or category of in vitro clinical tests,
means that an undetected inaccurate result from such in vitro
clinical test, or such category of in vitro clinical tests,
when used as intended--
``(A) would cause only minimal or immediately
reversible harm, and would lead to only a remote risk
of adverse patient impact or adverse public health
impact; or
``(B) sufficient mitigating measures are able to be
established and applied such that the in vitro clinical
test meets the standard described in subparagraph (A).
``(15) Mitigating measures.--The term `mitigating
measures'--
``(A) means controls, standards, and other
requirements that the Secretary determines, based on
evidence, are necessary--
``(i) for an in vitro clinical test, or a
category of in vitro clinical tests, to meet
the applicable standard; or
``(ii) to mitigate the risk of harm ensuing
from an undetected inaccurate result or
misinterpretation of a result; and
``(B) may include, as required by the Secretary, as
appropriate, applicable requirements regarding
labeling, conformance to performance standards and
consensus standards, performance testing, submission of
clinical data, advertising, website posting of
information, clinical studies, postmarket surveillance,
user comprehension studies, training, and confirmatory
laboratory, clinical findings, the history of the
developer, the role of a health professional in the
testing process, such as integration of the testing
laboratory into the direct medical care of the patient,
including direct interaction between the testing
laboratory and treating physician, or testing.
``(16) Moderate-risk.--The term `moderate-risk', with
respect to an in vitro clinical test or category of in vitro
clinical tests--
``(A) means a test or category of tests that is not
high-risk under the criteria under paragraph (9) or
low-risk under the criteria under paragraph (14); and
``(B) may include a test or category of tests that,
when used as intended, meet the criteria specified in
paragraph (9)(A) for high-risk, but for which one or
more mitigating measures are able to be established and
applied to prevent, mitigate, or detect an inaccurate
result or otherwise sufficiently mitigate the risk
resulting from an undetected inaccurate result, but are
not sufficient such that the test is low-risk under the
criteria in paragraph (14).
``(17) Specimen receptacle.--The term `specimen receptacle'
means an in vitro clinical test intended for taking,
collecting, holding, storing, or transporting of specimens
derived from the human body or for preparation, analysis, or in
vitro clinical examination for purposes described in section
201(ss)(1).
``(18) Technology.--The term `technology'--
``(A) means a set of control mechanisms, energy
sources, or operating principles--
``(i) that do not differ significantly
among multiple in vitro clinical tests; and
``(ii) for which design and development
(including analytical and clinical validation,
as applicable) of the tests would be addressed
in a similar manner or through similar
procedures; and
``(B) may include clot detection, colorimetric
(non-immunoassay), electrochemical (non-immunoassay),
enzymatic (non-immunoassay), flow cytometry,
fluorometry (non-immunoassay), immunoassay, mass
spectrometry or chromatography, microbial culture, next
generation sequencing, nephlometric or turbidimetric
(non-immunoassay), singleplex or multiplex non-NGS
nucleic acid analysis, slide-based technology,
spectroscopy, and any other technology, as the
Secretary determines appropriate.
``(19) Test.--The term `test', unless otherwise provided,
means an in vitro clinical test.
``(20) Valid scientific evidence.--The term `valid
scientific evidence'--
``(A) means, with respect to an in vitro clinical
test, evidence that--
``(i) has been generated and evaluated by
persons qualified by training or experience to
do so, using procedures generally accepted by
other persons so qualified; and
``(ii) forms an appropriate basis for
concluding by qualified experts whether the
applicable standard has been met by the in
vitro clinical test; and
``(B) may include evidence described in
subparagraph (A) consisting of--
``(i) peer-reviewed literature;
``(ii) clinical guidelines;
``(iii) reports of significant human
experience with an in vitro clinical test;
``(iv) bench studies;
``(v) case studies or histories;
``(vi) clinical data;
``(vii) consensus standards;
``(viii) reference standards;
``(ix) data registries;
``(x) postmarket data;
``(xi) real world data;
``(xii) clinical trials; and
``(xiii) data collected in countries other
than the United States if such data are
demonstrated to be appropriate for the purpose
of making a regulatory determination under this
subchapter.
``SEC. 587A. REGULATION OF IN VITRO CLINICAL TESTS.
``(a) In General.--No person shall introduce or deliver for
introduction into interstate commerce any in vitro clinical test,
unless--
``(1) an approval of an application filed pursuant to
subsection (a) or (b) of section 587B is effective with respect
to such in vitro clinical test;
``(2) the in vitro clinical test is offered under a
technology certification order under section 587D(b)(1); or
``(3) the test is exempt under sections 587C or 587G from
the requirements of section 587B.
``(b) Transfer or Sale of In Vitro Clinical Tests.--
``(1) Transfer and assumption of regulatory obligations.--
If ownership of an in vitro clinical test is sold or
transferred in such manner that the developer transfers the
regulatory submissions and obligations applicable under this
subchapter with respect to the test, the transferee or
purchaser becomes the developer of the test and shall have all
regulatory obligations applicable to such a test under this
subchapter. The transferee or purchaser shall update the
registration and listing information under section 587J for the
in vitro clinical test.
``(2) Transfer or sale of premarket approval.--
``(A) Notice required.--If a developer of an in
vitro clinical test transfers or sells the approval of
the in vitro clinical test, the transferor or seller
shall--
``(i) submit a notice of the transfer or
sale to the Secretary and update the
registration and listing information under
section 587J for the in vitro clinical test;
and
``(ii) submit a supplement to an
application if required under section 587B(h).
``(B) Effective date of approval transfer.--A
transfer or sale described in subparagraph (A) shall
become effective upon completion of a transfer or sale
described in paragraph (1) or the approval of a
supplement to an application under section 587B(h) if
required, whichever is later. The transferee or
purchaser shall update the registration and listing
information under section 587J for the in vitro
clinical test within 15 calendar days of the effective
date of the transfer or sale.
``(3) Transfer or sale of technology certification.--
``(A) Requirements for transfer or sale of
technology certification.--An unexpired technology
certification can be transferred or sold if the
transferee or purchaser--
``(i) is an eligible person under section
587D(a)(2); and
``(ii) maintains, upon such transfer or
sale, test design and quality requirements,
processes and procedures under the scope of
technology certification, and scope of the
technology certification identified in the
applicable technology certification order.
``(B) Notice required.--If a developer of an in
vitro clinical test transfers or sells a technology
certification order that has not expired, the
transferor or seller shall submit a notice of the
transfer or sale to the Secretary and shall update the
registration and listing information under section 587J
for all in vitro clinical tests covered by the
technology certification.
``(C) Effective date of technology certification
transfer.--The transfer of a technology certification
shall become effective upon completion of a transfer or
sale described in subparagraph (A). The transferee or
purchaser shall update the registration and listing
information under section 587J for the in vitro
clinical test within 30 calendar days of the effective
date of the technology certification transfer.
``(D) New technology certification required.--If
the requirements of subparagraph (A)(ii) are not met,
the technology certification order may not be
transferred and the transferee or purchaser of an in
vitro clinical test is required to submit an
application for technology certification and obtain a
technology certification order prior to offering the
test for clinical use.
``(c) Regulations.--The Secretary may issue regulations to
implement this subchapter.
``SEC. 587B. PREMARKET REVIEW.
``(a) Application.--
``(1) Filing.--Any developer may file with the Secretary an
application for premarket approval of an in vitro clinical test
under this subsection.
``(2) Transparency and predictability.--If a developer
files a premarket application under this section and provides
any additional documentation required under section 587D, the
in vitro clinical test that is the subject of the premarket
application may be utilized as the representative in vitro
clinical test reviewed by the Secretary to support a technology
certification order under section 587D.
``(3) Application content.--An application submitted under
paragraph (1) shall include the following, in such format as
the Secretary specifies:
``(A) General information regarding the in vitro
clinical test, including--
``(i) the name and address of the
applicant;
``(ii) the table of contents for the
application and the identification of the
information the applicant claims as trade
secret or confidential commercial or financial
information;
``(iii) a description of the test's design
and intended use, including the indications for
use; and
``(iv) a description regarding test
function and performance characteristics.
``(B) A summary of the data and information in the
application for the in vitro clinical test, including--
``(i) a brief description of the foreign
and domestic marketing history of the test, if
any, including a list of all countries in which
the test has been marketed and a list of all
countries in which the test has been withdrawn
from the market for any reason related to the
ability of the in vitro clinical test to meet
the applicable standard, if known by the
applicant;
``(ii) a description of benefit and risk
considerations related to the in vitro clinical
test, including a description of any applicable
adverse effects of the test on health and how
such adverse effects have been, or will be,
mitigated;
``(iii) a risk assessment of the test; and
``(iv) a description of how the data and
information in the application constitute valid
scientific evidence and support a showing that
the test meets the applicable standard under
section 587(2).
``(C) The signature of the developer filing the
premarket application or an authorized representative.
``(D) A bibliography of applicable published
reports and a description of any studies conducted,
including any unpublished studies related to such test,
that are known or that should reasonably be known to
the applicant, and a description of data and
information relevant to the evaluation of whether the
test meets the applicable standard.
``(E) Applicable information regarding the methods
used in, and the facilities or controls used for, the
development of the test to demonstrate compliance with
the applicable quality requirements under section 587K.
``(F) Information demonstrating compliance with any
relevant and applicable--
``(i) mitigating measures under section
587E; and
``(ii) standards established or recognized
under section 514 prior to the date of
enactment of the VALID Act of 2023, or, after
applicable standards are established or
recognized under section 587R, with such
standards.
``(G) Valid scientific evidence to support that the
test meets the applicable standard, which shall
include--
``(i) summary information for all
supporting validation studies performed,
including a description of the objective of the
study, a description of the experimental design
of the study, a description of any limitations
of the study, a brief description of how the
data were collected and analyzed, a brief
description of the results of each study, and
conclusions drawn from each study;
``(ii) raw data for each study, which may
include, as applicable, tabulations of data and
results; and
``(iii) for nonclinical laboratory studies
involving the test, if applicable, a statement
that studies were conducted in compliance with
applicable good laboratory practices.
``(H) To the extent the application seeks
authorization to make modifications to the test within
the scope of the approval that are not otherwise
permitted without premarket review under this
subchapter, a proposed change protocol that includes
validation procedures and acceptance criteria for
anticipated modifications that could be made to the
test within the scope of the approval.
``(I) Proposed labeling, in accordance with the
requirements of section 587L.
``(J) Such other data or information as the
Secretary may require in accordance with the least
burdensome requirements under section 587AA(c).
``(4) Regulation for premarket and abbreviated premarket
applications.--Not later than 3 years after the date of
enactment of the VALID Act of 2023, the Secretary shall
promulgate final regulations detailing the information to be
provided in a premarket application and abbreviated premarket
application under this section.
``(5) Refuse to file a premarket or abbreviated premarket
application.--The Secretary may refuse to file an application
under this section only for lack of completeness or legibility
of the application. If, after receipt of an application under
this section, the Secretary refuses to file such an
application, the Secretary shall provide to the developer,
within 45 calendar days of receipt of such application
submitted under this subsection or within 30 calendar days of
receipt of an application submitted under subsection (b), a
description of the reason for such refusal, and identify the
information required, if any, to allow for the filing of the
application.
``(6) Substantive review for deficient application.--If,
after receipt of an application under this section, the
Secretary determines that any portion of such application is
materially deficient, the Secretary shall provide to the
applicant a description of such material deficiencies and the
information required to resolve such deficiencies.
``(7) Inspections.--With respect to an application under
paragraph (1), preapproval inspections authorized by an
employee of the Food and Drug Administration or a person
accredited under section 587Q need not occur unless requested
by the Secretary.
``(b) Abbreviated Premarket Review.--
``(1) In general.--Any developer may file with the
Secretary an application for abbreviated premarket approval
for--
``(A) an instrument;
``(B) a specimen receptacle;
``(C) an in vitro clinical test that is moderate-
risk; or
``(D) an in vitro clinical test that is determined
by the Secretary to be eligible for abbreviated
premarket review under section 587F(a)(1)(B).
``(2) Application content.--An application under paragraph
(1) shall include--
``(A) the information required for applications
submitted under subsection (a)(3), except that
applications under paragraph (1) need not include--
``(i) quality requirement information; or
``(ii) raw data, unless requested in
writing by the Secretary, in accordance with
the least burdensome requirements under section
587AA(c), and with supervisory review and
concurrence prior to issuance of such request;
and
``(B) data, as applicable, to support software
validation, electromagnetic compatibility, and
electrical safety, and information demonstrating
compliance with maintaining quality systems
documentation.
``(3) Safety information.--The developer of an in vitro
clinical test specimen receptacle reviewed under this
subsection shall maintain safety information for such specimen
receptacle.
``(4) Inspections.--With respect to an application under
paragraph (1), preapproval inspections shall not be required
unless requested in writing by the Secretary, after supervisory
review and concurrence, because such inspection is considered
necessary to complete the review.
``(c) Instruments and Instrument Families.--
``(1) In general.--A developer of an instrument family
shall file with the Secretary an application for premarket
approval of one version of an instrument under this subsection.
Any modified versions of the instrument that generate a new
instrument within the same instrument family shall be exempt
from premarket review requirements of this section, provided
that the developer of such instrument or instrument family--
``(A) maintains documentation that the new
instrument is part of the instrument family, as defined
in section 587;
``(B) performs, documents, and maintains a risk
assessment (as described in subsection (a)(3)(B)(iii))
of the new instrument compared to the instrument
approved under subsection (b) and no new risks are
identified;
``(C) performs, documents, and maintains validation
and verification activities for the new instrument;
``(D) makes such documentation available to the
Secretary upon request; and
``(E) registers and lists the new instrument in
accordance with section 587J.
``(2) Test kits and test protocols.--With regard to a test
kit or test protocol that is approved under this section for
use on an approved instrument or an instrument exempt from
premarket review, including an instrument within an instrument
family under this section, a submission under this section
shall not be required for such test kit or test protocol in
order for it to be used on a new instrument within its
instrument family, provided that--
``(A) use of the test kit or test protocol with the
new instrument does not--
``(i) change the claims for the test kit or
test protocol, except as applicable, claims
regarding an instrument or instruments that can
be used with such test kit or test protocol;
``(ii) adversely affect performance of the
test kit or test protocol; or
``(iii) cause the test kit or test protocol
to no longer conform with performance standards
required under section 587R or comply with any
applicable mitigating measures under section
587E, conditions of approval under subsection
(e)(2)(B), or restrictions under section 587O;
``(B) the test developer does not identify any new
risks for the test kit or test protocol when using the
new instrument after conducting a risk assessment;
``(C) the test developer validates the use of the
new instrument with the test kit or test protocol and
maintains validation documentation;
``(D) the test kit or test protocol is not intended
for use--
``(i) in settings for which a certificate
of waiver is in effect under section 353 of the
Public Health Service Act;
``(ii) without a prescription;
``(iii) at home; or
``(iv) in testing donors, donations, and
recipients of blood, blood components, human
cells, tissues, cellular-based products, or
tissue-based products;
``(E) the test developer makes the documentation
described under subparagraph (C) available to the
Secretary upon request; and
``(F) the test developer updates the listing
information for the test kit or test protocol, as
applicable.
``(d) Amendments to an Application.--An applicant shall amend an
application submitted under subsection (a), (b), or (f) if the
applicant becomes aware of information that could reasonably affect an
evaluation under subsection (e) of whether the approval standard has
been met.
``(e) Action on an Application for Premarket Approval.--
``(1) Review.--
``(A) Disposition.--As promptly as possible, but
not later than 90 calendar days after an application
under subsection (a) is accepted for submission (unless
the Secretary determines that an extension is necessary
to review one or more major amendments to the
application), or not later than 60 calendar days after
an application under subsection (b) is accepted for
submission or a supplemental application under
subsection (f) is accepted for submission, the
Secretary, after considering any applicable report and
recommendations pursuant to advisory committees under
section 587H, shall issue an order approving the
application, unless the Secretary finds that the
grounds for approval in paragraph (2) are not met.
``(B) Reliance on proposed labeling.--In
determining whether to approve or deny an application
under paragraph (1), the Secretary shall rely on the
indications for use included in the proposed labeling,
provided that such labeling is not false or misleading
based on a fair evaluation of all material facts.
``(2) Approval of an application.--
``(A) In general.--The Secretary shall approve an
application submitted under subsection (a) or (b) with
respect to an in vitro clinical test if the Secretary
finds that the applicable standard is met, and--
``(i) the applicant is in compliance with
applicable quality requirements in section
587K;
``(ii) the application does not contain a
false statement or misrepresentation of
material fact;
``(iii) based on a fair evaluation of all
material facts, the proposed labeling is
truthful and non-misleading and complies with
the requirements of section 587L;
``(iv) the applicant permits, if requested,
authorized employees of the Food and Drug
Administration and persons accredited under
section 587Q an opportunity to inspect pursuant
to section 704;
``(v) the test conforms with any applicable
performance standards required under section
587R and any applicable mitigating measures
under section 587E;
``(vi) all nonclinical laboratory studies
and clinical investigations involving human
subjects that are described in the application
were conducted in a manner that meets the
applicable requirements of this subchapter; and
``(vii) other data and information the
Secretary may require under subsection
(a)(3)(J) support approval.
``(B) Conditions of approval.--An order approving
an application pursuant to this section may require
reasonable conditions of approval for the in vitro
clinical test, which may include conformance with
applicable mitigating measures under section 587E,
restrictions under section 587O, and performance
standards under section 587R.
``(C) Publication.--The Secretary shall publish an
order for each application approved pursuant to this
paragraph on the public website of the Food and Drug
Administration and make publicly available a summary of
the data used to approve such application. In making
the order and summary publicly available, the Secretary
shall not disclose any information that--
``(i) is confidential commercial
information or trade secret information subject
to section 552(b)(4) of title 5, United States
Code, or section 1905 of title 18, United
States Code; or
``(ii) could compromise national security.
``(3) Review of denials.--An applicant whose application
submitted under this section has been denied approval under
this subsection may, by petition filed not more than 60
calendar days after the date on which the applicant receives
notice of such denial, obtain review of the denial in
accordance with section 587P.
``(f) Supplements to an Approved Application.--
``(1) Risk analysis.--Prior to implementing any
modification to an in vitro clinical test, the holder of the
application approved under subsection (e) for such test shall
perform risk analyses in accordance with this subsection,
unless such modification is included in the change protocol
submitted by the applicant and approved under this section or
exempt under section 587C.
``(2) Supplement requirement.--
``(A) In general.--If the holder of an application
of an approved in vitro clinical test makes a
modification to such in vitro clinical test, except as
provided in subparagraph (C), or otherwise specified by
the Secretary, the holder of the application approved
under subsection (e) for an in vitro clinical test
shall submit a supplemental application to the
Secretary. The holder of the application may not
implement such modification to the in vitro clinical
test until such supplemental application is approved.
The information required in a supplemental application
is limited to what is needed to support the change.
``(B) Change protocols.--The holder of an approved
application may submit under this paragraph a
supplemental application to modify the change protocol
for a test or to request a change protocol for a test.
``(C) Exceptions.--Notwithstanding subparagraphs
(A) and (B), and so long as the holder of an approved
application submitted under subsection (a) or (b) for
an in vitro clinical test does not add a manufacturing
site, or change activities at an existing manufacturing
site, with respect to the test, the holder of an
approved application may, without submission of a
supplemental application, implement the following
modifications to the test:
``(i) Modifications in accordance with an
approved change protocol under subsection
(a)(3)(H).
``(ii) Modifications that are exempt under
section 587C(a)(6).
``(iii) Labeling changes that are
appropriate to address a safety concern, except
such labeling changes that include any of the
following remain subject to subparagraph (A):
``(I) A change to the indications
for use of the test.
``(II) A change to the performance
claims made with respect to the test.
``(III) A change that adversely
affects performance of the test.
``(D) Reporting for certain modifications made
pursuant to a change protocol.--The holder of an
application approved under subsection (e), with an
approved change protocol under subsection (a)(2)(H) for
such in vitro clinical test shall--
``(i) report any modification to such test
made pursuant to such change protocol approved
under subsection (a)(3)(H) in a submission
under section 587J(c)(2)(B); and
``(ii) include in such report--
``(I) a description of the
modification;
``(II) the rationale for
implementing such modification; and
``(III) as applicable, a summary of
the evidence supporting that the test,
as modified, meets the applicable
standard, complies with performance
standards required under section 587Q,
and complies with any mitigating
measures established under section 587E
and any restrictions under section
587O.
``(E) Reporting for certain safety related labeling
changes.--The holder of the application for an in vitro
clinical test approved under subsection (e) shall--
``(i) report to the Secretary any
modification to the test described in
subparagraph (C)(iii) not more than 30 days
after the date on which the test, with the
modification, is introduced into interstate
commerce; and
``(ii) include in the report--
``(I) a description of the change
or changes;
``(II) the rationale for
implementing such change or changes;
and
``(III) a description of how the
change or changes were evaluated.
``(3) Contents of supplement.--Unless otherwise specified
by the Secretary, a supplement under this subsection shall
include--
``(A) for modifications other than manufacturing
site changes requiring a supplement--
``(i) a description of the modification;
``(ii) data relevant to the modification to
demonstrate that the applicable standard is
met, not to exceed data requirements for the
original submission;
``(iii) acceptance criteria; and
``(iv) any revised labeling; and
``(B) for manufacturing site changes--
``(i) the information listed in
subparagraph (A); and
``(ii) information regarding the methods
used in, or the facilities or controls used
for, the development of the test to demonstrate
compliance with the applicable quality
requirements under section 587K.
``(4) Additional data.--The Secretary may require, when
necessary, data to evaluate a modification to an in vitro
clinical test that is in addition to the data otherwise
required under the preceding paragraphs if the data request is
in accordance with the least burdensome requirements under
section 587AA(c).
``(5) Conditions of approval.--In an order approving a
supplement under this subsection, the Secretary may require
conditions of approval for the in vitro clinical test,
including compliance with restrictions under section 587O and
conformance to performance standards under section 587R.
``(6) Approval.--The Secretary shall approve a supplement
under this subsection if--
``(A) the data demonstrate that the modified in
vitro clinical test meets the applicable standard; and
``(B) the holder of the application approved under
subsection (e) for the test has demonstrated compliance
with applicable quality and inspection requirements, as
applicable and appropriate.
``(7) Publication.--The Secretary shall publish on the
public website of the Food and Drug Administration notice of
any order approving a supplement under this subsection provided
that doing so does not disclose any information that--
``(A) is trade secret or confidential commercial or
financial information; or
``(B) could compromise national security.
``(8) Review of denial.--An applicant whose supplement
under this subsection has been denied approval may, by petition
filed on or before the 60th calendar day after the date upon
which the applicant receives notice of such denial, obtain
review of the denial in accordance with section 587P.
``(g) Withdrawal and Temporary Suspension of Approval.--
``(1) Order withdrawing approval.--
``(A) In general.--The Secretary may, after
providing due notice and an opportunity for an informal
hearing to the holder of an approved application for an
in vitro clinical test under this section, issue an
order withdrawing approval of the application if the
Secretary finds that--
``(i) the grounds for approval under
subsection (e) are no longer met;
``(ii) there is a reasonable likelihood
that the test would cause death or serious
adverse health consequences, including by
causing the absence, significant delay, or
discontinuation of life-saving or life
sustaining medical treatment;
``(iii) the holder of the approved
application--
``(I) has failed to, or repeatedly
or deliberately failed to, maintain
records to make reports, as required
under section 587M;
``(II) has refused to permit access
to, or copying or verification of such
records, as required under section 704;
``(III) has not complied with the
requirements of section 587K; or
``(IV) has not complied with any
mitigating measure required under
section 587E or restriction under
section 587O; or
``(iv) the labeling of such in vitro
clinical test, based on a fair evaluation of
all material facts, is false or misleading in
any particular and was not corrected within a
reasonable time after receipt of written notice
from the Secretary of such fact.
``(B) Content.--An order under subparagraph (A)
withdrawing approval of an application shall state each
ground for withdrawal and shall notify the holder of
such application 60 calendar days prior to issuing such
order.
``(C) Publication.--The Secretary shall publish any
order under subparagraph (A) on the public website of
the Food and Drug Administration provided that doing so
does not disclose--
``(i) any information that is trade secret
or confidential commercial or financial
information; or
``(ii) any other information that the
Secretary determines, if published, could
compromise national security.
``(2) Order of temporary suspension.--If, after providing
due notice and an opportunity for an informal hearing to the
holder of an approved application for an in vitro clinical test
under this section, the Secretary determines, based on
scientific evidence, that there is a reasonable likelihood that
the in vitro clinical test would cause death or serious adverse
health consequences, such as by causing the absence,
significant delay, or discontinuation of life-saving or life-
sustaining medical treatment, the Secretary shall, by order,
temporarily suspend the approval of the application. If the
Secretary issues such an order, the Secretary shall proceed
expeditiously under paragraph (1) to withdraw approval of such
application.
``(3) Appeal withdrawing approval and orders of temporary
suspensions.--An order of withdrawal or an order of temporary
suspension may be appealed under 587P.
``SEC. 587C. EXEMPTIONS.
``(a) In General.--The following in vitro clinical tests are exempt
from premarket review under section 587B, and may be lawfully offered
subject to other applicable requirements of this Act:
``(1) Tests exempt from section 510(k).--
``(A) Exemption.--An in vitro clinical test is
exempt from premarket review under section 587B and may
be lawfully offered subject to the other applicable
requirements of this Act, if the developer of the in
vitro clinical test--
``(i) maintains documentation demonstrating
that the test meets and continues to meet the
criteria set forth in subparagraph (B); and
``(ii) makes such documentation available
to the Secretary upon request.
``(B) Criteria for exemption.--An in vitro clinical
test is exempt as specified in subparagraph (A) if such
test--
``(i)(I)(aa) was offered for clinical use
prior to the date of enactment of the VALID Act
of 2023; and
``(bb) immediately prior to such date of
enactment was exempt pursuant to subsection (l)
or (m)(2) of section 510 from the requirements
for submission of a report under section
510(k); or
``(II)(aa) was not offered for clinical use
prior to such date of enactment;
``(bb) is not an instrument; and
``(cc) falls within a category of tests
that was exempt from the requirements for
submission of a report under section 510(k) as
of such date of enactment (including class II
devices and excluding class I devices described
in section 510(l));
``(ii) meets the applicable standard as
described in section 587(2);
``(iii) is not offered with labeling and
advertising that is false or misleading; and
``(iv) is not likely to cause or contribute
to serious adverse health consequences.
``(C) Effect on special controls.--For any in vitro
clinical test, or category of in vitro clinical tests,
that is exempt from premarket review based on the
criteria in subparagraph (B), any special control that
applied to a device within a predecessor category
immediately prior to the date of enactment of the VALID
Act of 2023 shall be deemed a mitigating measure
applicable under section 587E to an in vitro clinical
test within the successor category, except to the
extent such mitigating measure is withdrawn or changed
in accordance with section 587E.
``(D) Near-patient testing.--Not later than 1 year
after the date of enactment of the VALID Act of 2023,
the Secretary shall issue draft guidance indicating
categories of tests that shall be exempt from premarket
review under section 587B when offered for near-patient
testing (point of care), which were not exempt from
submission of a report under section 510(k) pursuant to
subsection (l) or (m)(2) of section 510 and regulations
imposing limitations on exemption for in vitro devices
intended for near-patient testing (point of care).
``(2) Low-risk tests.--
``(A) Exemption.--An in vitro clinical test is
exempt from premarket review under section 587B and may
be lawfully offered subject to the other applicable
requirements of this Act, including section 587J(b), if
such test meets the definition of low-risk under
section 587 and if the developer of the test--
``(i) maintains documentation demonstrating
that the in vitro clinical test meets and
continues to meet the criteria set forth in
subparagraph (B); and
``(ii) makes such documentation available
to the Secretary upon request.
``(B) Criteria for exemption.--An in vitro clinical
test is exempt as specified in subparagraph (A) if--
``(i) the in vitro clinical test meets the
applicable standard as described in 587(2);
``(ii) the labeling and advertising are not
false or misleading;
``(iii) the in vitro clinical test is not
likely to cause or contribute to serious
adverse health consequences; and
``(iv) the in vitro clinical test falls
within a category of tests listed as described
in subparagraph (C).
``(C) List of low-risk tests.--
``(i) In general.--The Secretary shall
maintain, and make publicly available on the
website of the Food and Drug Administration, a
list of in vitro clinical tests, and categories
of in vitro clinical tests, that are low-risk
in vitro clinical tests for purposes of the
exemption under this paragraph.
``(ii) Inclusion.--The list under clause
(i) shall consist of--
``(I) all in vitro clinical tests
and categories of in vitro clinical
tests that are exempt from premarket
review pursuant to paragraph (1) or
this paragraph; and
``(II) all in vitro clinical tests
and categories of in vitro clinical
tests that are designated by the
Secretary pursuant to subparagraph (D)
as low-risk for purposes of this
paragraph.
``(D) Designation of tests and categories.--Without
regard to subchapter II of chapter 5 of title 5, United
States Code, the Secretary may designate, in addition
to the tests and categories described in subparagraph
(C)(i), additional in vitro clinical tests, and
categories of in vitro clinical tests, as low-risk in
vitro clinical tests for purposes of the exemption
under this paragraph. The Secretary may make such a
designation on the Secretary's own initiative or in
response to a request by a developer pursuant to
subsection (a) or (b) of section 587F. In making such a
designation for a test or category of tests, the
Secretary shall consider--
``(i) whether the test, or category of
tests, is low-risk;
``(ii) the existence of and ability to
develop mitigating measures sufficient for such
test category to meet the low-risk standard;
and
``(iii) such other factors as the Secretary
determines to be appropriate for the protection
of the public health.
``(3) Humanitarian test exemption.--
``(A) In general.--An in vitro clinical test that
meets the criteria under subparagraph (B) is exempt
from premarket review under section 587B and may be
lawfully offered subject to the other applicable
requirements of this subchapter, if the developer of
the test--
``(i) maintains documentation (which may
include literature citations in specialized
medical journals, textbooks, specialized
medical society proceedings, and governmental
statistics publications, or, if no such studies
or literature citations exist, credible
conclusions from appropriate research or
surveys) demonstrating that such test meets and
continues to meet the criteria described in
this subsection; and
``(ii) makes such documentation available
to the Secretary upon request.
``(B) Criteria for exemption.--An in vitro clinical
test is exempt as described in subparagraph (A) if--
``(i) the in vitro clinical test is
intended by the developer for use for a
diagnostic purpose for--
``(I) a noncontagious disease or
condition that affects not more than
10,000 (or such other higher number
determined by the Secretary)
individuals in the United States per
year; or
``(II) a contagious disease or
condition that affects not more than
1,500 individuals in the United States
per year;
``(ii) the in vitro clinical test meets the
applicable standard described in section
587(2);
``(iii) the labeling and advertising for
the in vitro clinical test are not false or
misleading;
``(iv) the in vitro clinical test is not
likely to cause or contribute to serious
adverse health consequences; and
``(v) the in vitro clinical test is not
intended for screening.
``(C) Exception for certain tests.--An in vitro
clinical test intended to inform the use of a specific
individual or specific type of biological product,
drug, or device shall be eligible for an exemption from
premarket review under this subsection only if, the
developer submits a request under section 587F(e) for
informal feedback and the Secretary determines that
such in vitro clinical test is eligible for an
exemption from premarket review under this subsection.
``(4) Custom tests and low-volume tests.--An in vitro
clinical test is exempt from premarket review under section
587B, quality requirements under section 587K, and listing
requirements under section 587J, and may be lawfully offered
subject to the other applicable requirements of this Act, if--
``(A) such in vitro clinical test--
``(i) is a test protocol performed for not
more than 5 patients per year (or such other
higher number determined by the Secretary), in
a laboratory certified by the Secretary under
section 353 of the Public Health Service Act
that--
``(I) meets the requirements to
perform tests of high-complexity in
which the test protocol was developed;
or
``(II) meets the requirements to
perform tests of high-complexity within
the same corporate organization and
having common ownership by the same
parent corporation as the laboratory in
which such test protocol was developed;
or
``(ii) is an in vitro clinical test
developed to diagnose a unique pathology or
physical condition of a specific patient or
patients (including an in vitro clinical test
modified for such purpose), upon the
prescription or order of a health care
practitioner licensed to prescribe or order
such test, or a health care professional or
other specially qualified person designated
under regulations to prescribe or order such
test, for which no other in vitro clinical test
is commercially available in the United States,
and is--
``(I) not intended for use with
respect to more than 5 (or such other
higher number determined by the
Secretary) other patients; and
``(II) not included in any test
menu or template test report or other
promotional materials, and is not
otherwise advertised; and
``(B) the developer of the in vitro clinical test--
``(i) maintains documentation demonstrating
that such test meets the applicable criteria
described in subparagraph (A);
``(ii) makes such documentation, such as a
prescription order requesting the custom test
for an individual patient, available to the
Secretary upon request; and
``(iii) informs the Secretary, on an annual
basis, in a manner prescribed by the Secretary
by guidance, that such test was offered.
``(5) In vitro clinical tests under a technology
certification order.--An in vitro clinical test that is within
the scope of a technology certification order under section
587D is exempt from premarket review under section 587B.
``(6) Modified tests.--
``(A) In general.--An in vitro clinical test that
is modified is exempt from premarket review under
section 587B if--
``(i) the modification is made by--
``(I) the developer that obtained
premarket approval for the unmodified
version of the test under section 587B;
or
``(II) a clinical laboratory
certified by the Secretary under
section 353 of the Public Health
Service Act that meets the requirements
for performing high complexity testing,
to a lawfully offered in vitro clinical
test, including another developer's
lawfully offered in vitro clinical
test, excluding investigational in
vitro clinical tests offered under
section 587S, and the modified test is
performed--
``(aa) in the same clinical
laboratory in which it was
developed for which a
certification is still in
effect under section 353 that
meets the requirements to
perform tests of high
complexity;
``(bb) by another clinical
laboratory for which a
certificate is in effect under
section 353 that meets the
requirements to perform tests
of high complexity, is within
the same corporate
organization, and has common
ownership by the same parent
corporation as the laboratory
in which the test was
developed; or
``(cc) by a clinical
laboratory for which a
certificate is in effect under
section 353 that meets the
requirements to perform tests
of high complexity and is
within a public health
laboratory network coordinated
or managed by the Centers for
Disease Control and Prevention,
if the test was developed by
the Centers for Disease Control
and Prevention or another
laboratory within such public
health laboratory network;
``(ii) the modification does not--
``(I) constitute a significant
change to the indications for use,
except for changes to a specimen type,
as specified in the guidance issued
under subparagraph (E);
``(II) cause the test to no longer
comply with applicable mitigating
measures under section 587E or
restrictions under section 587O;
``(III) significantly change
performance claims or significantly and
adversely change performance, unless
provided for under an approved change
protocol under section 587B(a)(3)(H);
or
``(IV) constitute an adverse change
in the safety of the in vitro clinical
test for individuals who come in
contact with the in vitro clinical
test;
``(iii) the test meets the applicable
standard as described in section 587(2);
``(iv) the labeling and advertising are not
false or misleading; and
``(v) the test is not likely to cause or
contribute to serious adverse health
consequences.
``(B) Certain modifications.--A modification to
extend specimen stability is exempt from premarket
review under section 587B if the modified test meets
the requirements in clauses (ii) through (v) of
subparagraph (A).
``(C) Modifications under a change protocol.--
Notwithstanding subparagraph (A), a modification made
under a change protocol pursuant to subsection
(a)(2)(H) of section 587B is exempt from review under
such section.
``(D) Documentation.--A person who modifies an in
vitro clinical test in a manner that is a modification
described in this paragraph shall--
``(i) document the modification that was
made and the basis for determining that the
modification, considering the changes
individually and collectively, is a type of
modification described in subparagraph (A),
(B), or (C); and
``(ii) provide such documentation to the
Secretary upon request or inspection.
``(E) Guidance.--Not later than 30 months after the
date of enactment of the VALID Act of 2023, the
Secretary shall issue guidance regarding the in vitro
clinical tests that are modified and exempt from
premarket review under section 587B pursuant to this
paragraph. Such guidance shall include considerations
for changes to a specimen type that may be made by a
developer without the requirement of premarket review
under 587B.
``(b) Manual Tests.--
``(1) Exemption.--An in vitro clinical test is exempt from
all requirements of this subchapter if the output of such in
vitro clinical test is the result of direct, manual
observation, without the use of automated instrumentation or
software for intermediate or final interpretation, by a
qualified laboratory professional, and such in vitro clinical
test--
``(A) is developed and used within a single
clinical laboratory for which a certificate is in
effect under section 353 of the Public Health Service
Act that meets the requirements under section 353 for
performing high-complexity testing;
``(B) is not a specimen receptacle, instrument, or
an in vitro clinical test that includes an instrument
or specimen receptacle that is not approved under or
exempt from section 587B;
``(C) is not a high-risk test, or is a high-risk
test that the Secretary has determined meets at least
one condition in paragraph (2) and is otherwise
appropriate for this exemption; and
``(D) is not intended for testing donors,
donations, or recipients of blood, blood components,
human cells, tissues, cellular-based products, or
tissue-based products.
``(2) High-risk test limitation or condition.--A high-risk
test may be exempt under paragraph (1) from the requirements of
this subchapter only if--
``(A) no components or parts of such test,
including any reagent, is introduced into interstate
commerce under the exemption under subsection (e), and
any article for taking or deriving specimens from the
human body used in conjunction with the test remains
subject to the requirements of this subchapter; or
``(B) the test has been developed in accordance
with the applicable test design and quality
requirements under section 587K.
``(c) Public Health Surveillance Activities.--
``(1) In general.--The provisions of this subchapter shall
not apply to a test intended by the developer to be used solely
for public health surveillance activities.
``(2) Exclusion.--An in vitro clinical test used for public
health surveillance activities is not excluded from the
provisions of this subchapter pursuant to this subsection if
such test is intended for use in making clinical decisions for
individual patients.
``(d) General Laboratory Equipment.--As set forth in section
201(ss)(3)(C), general purposes laboratory equipment is not an in vitro
clinical tests and is not subject to the requirements of this
subchapter.
``(e) Components and Parts.--
``(1) In general.--Subject to paragraph (2), a component or
part described in section 201(ss)(2)(G) is--
``(A) exempt from the requirements of this
subchapter if it is intended for further development as
described in paragraph (3); or
``(B) subject to the requirements of this
subchapter and regulated based on its risk when used as
intended by the developer, notwithstanding its
subsequent use by a developer as a component, part, or
raw material of another in vitro clinical test.
``(2) Inapplicability to other tests.--Notwithstanding
paragraph (1), an in vitro clinical test that is described in
section 201(ss)(1)(B) and that uses a component or part
described in such subparagraph shall be subject to the
requirements of this subchapter, unless the test is otherwise
exempt under this section.
``(3) Further development.--A component, part, or raw
material (as described in paragraph (1)) is intended for
further development (for purposes of such paragraph) if--
``(A) it is intended solely for use in the
development of another in vitro clinical test; and
``(B) in the case of such a test that is introduced
or delivered for introduction into interstate commerce
after the date of enactment of the VALID Act of 2023,
the labeling of such test bears the following
statement: `This product is intended solely for further
development of an in vitro clinical test and is exempt
from FDA regulation. This product must be evaluated by
the in vitro clinical test developer if it is used with
or in the development of an in vitro clinical test.'.
``(f) General Exemption Authority.--The Secretary may, by order
published in the Federal Register following notice and an opportunity
for comment, exempt a class of persons from any section under this
subchapter upon a finding that such exemption is appropriate for the
protection of the public health and other relevant considerations.
``(g) Other Exemptions.--An in vitro clinical test that is intended
solely for use in forensic analysis or law enforcement activity is
exempt from the requirements of this subchapter. An in vitro clinical
test that is intended for use in making clinical decisions for
individual patients, or whose individually identifiable results may be
reported back to an individual patient or the patient's health care
provider, even if also intended for forensic analysis or law
enforcement purposes, is not intended solely for forensic analysis or
law enforcement for purposes of this subsection.
``(h) Revocation.--
``(1) In general.--The Secretary may revoke any exemption
under this section with respect to in vitro clinical tests with
the same indications for use if new clinical information
indicates that the exemption of an in vitro clinical test or
tests from premarket review under section 587B has a reasonable
probability of severe adverse health consequences, including
the absence, delay, or discontinuation of appropriate medical
treatment.
``(2) Process.--Any action under paragraph (1) shall be
made by publication of a notice of such proposed action on the
website of the Food and Drug Administration, the consideration
of comments to a public docket on such proposal, and
publication of a final action on such website within 60
calendar days of the close of the comment period posted to such
public docket, notwithstanding subchapter II of chapter 5 of
title 5, United States Code.
``(i) Pre-Analytical Instrument.--A pre-analytical instrument is
exempt from premarket review under section 587B and may be lawfully
offered subject to the other applicable requirements of this Act, if
either of the following applies:
``(1) Such instrument provides additional information
regarding the sample or performs an action on the sample but is
not preparing or processing the sample and does not perform any
function of an analytical instrument. Such types of pre-
analytical instruments include barcode readers, sample movers,
and sample identifiers.
``(2) Such instrument processes or prepares the sample
prior to use on an analytical instrument, does not perform any
function of an analytical instrument, and does not select,
isolate, or prepare a part of a sample based on specific
properties. Such types of pre-analytical instruments may
include sample mixers, DNA extractors and those used to dilute
samples.
``SEC. 587D. TECHNOLOGY CERTIFICATION.
``(a) Definitions.--In this section:
``(1) Eligible in vitro clinical test.--The term `eligible
in vitro clinical test' means an in vitro clinical test that is
not--
``(A) a component or part of an in vitro clinical
test as described in section 201(ss)(2)(G) unless it is
a component or part and is regulated based on its own
risk under section 587C(e)(1)(B) or as part of an
otherwise eligible in vitro clinical test;
``(B) an instrument under section 201(ss)(2)(D) or
an in vitro clinical test that includes an instrument
that is subject to section 587B, but is not approved
under, or exempt from, section 587B;
``(C) a specimen receptacle under section
201(ss)(2)(E) or an in vitro clinical test that
includes a specimen receptacle that is subject to
section 587B, but is not approved under, or exempt
from, section 587B;
``(D) an in vitro clinical test, including reagents
used in such tests, intended for use for testing
donors, donations, and recipients of blood, blood
components, human cells, tissues, cellular-based
products, or tissue-based products;
``(E) high-risk;
``(F) a combination product, unless such test has
been determined to be eligible to be introduced into
interstate commerce under a technology certification
order pursuant to the regulatory pathway designation
process described in section 587F, or as described in
subsection (k), and the drug or biological product
constituent part complies with the requirements of
section 503(g) applicable to the drug or biological
product; or
``(G) a first-of-a-kind in vitro clinical test,
unless such test has been determined to be eligible to
be introduced into interstate commerce under a
technology certification order pursuant to the
regulatory pathway designation process described in
section 587F, or as described in subsection (k).
``(2) Eligible person.--The term `eligible person' means an
in vitro clinical test developer unless such developer--
``(A) is a laboratory subject to section 353 of the
Public Health Service Act and does not have in effect a
certificate applicable to the category of laboratory
examination or other procedure;
``(B) was a laboratory, or an owner or operator or
any employee of a laboratory, found to have committed a
significant violation of section 353 of the Public
Health Service Act that resulted in a suspended,
revoked, or limited certificate within the 2-year
period preceding the date of the submission of the
application for a technology certificate under
subsection (c) and such violation has not been
resolved; or
``(C) has been found to have submitted information
to the Secretary, or otherwise disseminated
information, that--
``(i) made false or misleading statements
relevant to the requirements of this
subchapter; or
``(ii) violated any requirement of this
Act, where such violation exposed individuals
to serious risk of illness, injury, or death,
unless--
``(I) such violation has been
resolved; or
``(II) such violation is not
pertinent to any in vitro clinical test
within the scope of the technology
certification that such developer
seeks.
``(b) Applicability.--
``(1) In general.--An in vitro clinical test is not subject
to section 587B and may be introduced into interstate commerce
if the in vitro clinical test--
``(A) is an eligible in vitro clinical test;
``(B) is developed by an eligible person;
``(C) falls within the scope of a technology
certification order issued under this section and that
is in effect;
``(D) complies with the conditions of the
technology certification order, including with
applicable mitigating measures under section 587E,
restrictions under section 587O, and performance
standards under section 587R; and
``(E) meets the applicable standard described in
section 587(2).
``(2) Scope.--
``(A) In general.--Subject to subparagraph (B), the
scope of a technology certification order issued under
this section shall apply to one or more technologies
with multiple in vitro clinical tests utilizing a
technology that does not significantly differ in
control mechanisms, energy sources, or operating
principles and for which development, including design,
and analytical and clinical validation, of the in vitro
clinical tests would be addressed through similar
procedures, and be no broader than--
``(i) a single technology type; or
``(ii) a fixed combination of technologies.
``(B) Technology type.--A technology type described
in this paragraph may include clot detection,
colorimetric (non-immunoassay), electrochemical (non-
immunoassay), enzymatic (non-immunoassay), flow
cytometry, fluorometry (non-immunoassay), immunoassay,
mass spectrometry or chromatography, microbial culture,
next generation sequencing, nephlometric or
turbidimetric (non-immunoassay), singleplex or
multiplex non-NGS nucleic acid analysis, slide-based
technology, spectroscopy, and any other technology, as
the Secretary determines appropriate.
``(c) Application for Technology Certification.--
``(1) In general.--A developer seeking a technology
certification order shall submit an application under this
subsection, which shall contain the information specified under
paragraph (2).
``(2) Content of application.--A developer that submits an
application for a technology certification shall include all
necessary information to make a showing that all eligible in
vitro clinical tests developed within the scope of the
technology certification order will meet the applicable
standard, including--
``(A) the name and address of the developer;
``(B) a table of contents for the application and
the identification of the information the developer
claims as trade secret or confidential commercial or
financial information;
``(C) the signature of the individual filing the
application or an authorized representative;
``(D) a statement identifying the scope of the
proposed technology certification intended to be
introduced into interstate commerce under the
application;
``(E) information establishing that the developer
submitting the application is an eligible person;
``(F) quality procedures showing that eligible in
vitro clinical tests covered under the technology
certification will conform to the applicable quality
requirements of section 587K with respect to--
``(i) design controls, including related
purchasing controls and acceptance activities;
``(ii) complaint investigation, adverse
event reporting, and corrections and removals;
and
``(iii) process validation, as applicable;
``(G) procedures for analytical and clinical
validation, including all procedures for validation,
verification, and acceptance criteria, and an
explanation as to how such procedures, when used,
provide a showing that eligible in vitro clinical tests
within the proposed scope of the technology
certification order are analytically and clinically
valid;
``(H) procedures that provide a showing that in
vitro clinical tests covered by the proposed scope of
the technology certification order will be safe for
individuals who come into contact with in vitro
clinical tests covered by such order;
``(I) a proposed listing submission under section
587J(b) for in vitro clinical tests that the developer
intends to introduce into interstate commerce upon
receiving a technology certification order, which shall
not be construed to limit the developer from
introducing additional tests not included in such
submission under the same technology certification
order;
``(J) information concerning one or more
representative in vitro clinical tests, including--
``(i) a test within the scope of the
technology certification application with the
appropriate analytical complexity at the time
of the submission of the application under this
section to serve as the representative test;
``(ii) the information specified in
subsection (a) or (b) of section 587B, as
applicable, for the representative in vitro
clinical test or tests, unless the Secretary
determines that such information is not
necessary;
``(iii) a summary of a risk assessment of
the in vitro clinical test;
``(iv) an explanation of the choice of the
representative in vitro clinical test or tests
for the technology certification application
and how such test adequately demonstrates the
range of procedures that the developer includes
in the application under subparagraphs (F),
(G), (H), and (I); and
``(v) a brief explanation of the ways in
which the procedures included in the
application under subparagraphs (F), (G), (H),
and (I) have been applied to the representative
in vitro clinical test or tests; and
``(K) such other information necessary to make a
determination on a technology certification application
as the Secretary may determine necessary.
``(3) Reference to existing applications.--With respect to
the content requirements in the technology certification
application described in paragraph (2), a developer may
incorporate by reference any content of an application
previously submitted by the developer.
``(d) Action on an Application for Technology Certification.--
``(1) Secretary response.--
``(A) In general.--As promptly as practicable, and
not later than 90 days after receipt of an application
under subsection (c), the Secretary shall--
``(i) if the Secretary finds that all of
the grounds in paragraph (3) are met, issue a
technology certification order granting the
application, which--
``(I) may include reasonable
conditions of certification; and
``(II) shall specify the scope of
the technology certification; or
``(ii) deny the application, if the
Secretary finds (and sets forth the basis of
such finding as part of or accompanying such
denial) that one or more grounds for granting
the application specified in paragraph (3) are
not met.
``(B) Extension.--The timeline described in
subparagraph (A) may be extended by mutual agreement
between the Secretary and the applicant.
``(2) Deficient applications.--
``(A) In general.--If, after receipt of an
application under this section, the Secretary
determines that any portion of such application is
deficient, the Secretary, not later than 60 days after
receipt of such application, shall provide to the
applicant a description of such deficiencies and
identify the information required to resolve such
deficiencies.
``(B) Converting to premarket applications.--When
responding to the deficiency letter, the developer may
convert the application for technology certification
under subsection (c) into a premarket application under
section 587B.
``(3) Technology certification order.--The Secretary shall
issue an order granting a technology certification under this
section if, on the basis of the information submitted to the
Secretary as part of the application and any other information
with respect to such applicant, the Secretary finds that--
``(A) there is a showing that in vitro clinical
tests within the scope of the technology certification
order will meet the applicable standard;
``(B) the methods used in, and the facilities or
controls used for, the development of eligible in vitro
clinical tests covered by the proposed scope of the
technology certification conform to the applicable
requirements of section 587K with respect to--
``(i) design controls, including related
purchasing controls and acceptance activities;
``(ii) complaint investigation, adverse
event reporting, and corrections and removals;
and
``(iii) process validation, as applicable;
``(C) based on a fair evaluation of all material
facts, the applicant's proposed labeling and
advertising are not false or misleading in any
particular;
``(D) the application does not contain a false
statement of material fact;
``(E) there is a showing that the representative in
vitro clinical test or tests--
``(i) meet the applicable standard; and
``(ii) reasonably represent the range of
procedures required to be submitted in the
application;
``(F) the applicant has agreed to permit, upon
request, authorized employees of the Food and Drug
Administration or persons accredited, or recognized
under this Act, an opportunity to inspect at a
reasonable time and in a reasonable manner the
facilities and all pertinent equipment, finished and
unfinished materials, containers, and labeling therein,
including all things (including records, files, papers,
and controls) bearing on whether an in vitro clinical
test is adulterated, misbranded, or otherwise in
violation of this Act, and permits such authorized
employees or persons accredited under this Act to view
and to copy and verify all records pertinent to the
application and the in vitro clinical test; and
``(G) based on other data and information the
Secretary may require under subsection (c)(2)(K), the
Secretary finds that such data and information support
granting a technology certification order.
``(4) Review of denials.--An applicant whose application
has been denied under this subsection may obtain review of such
denial under section 587P.
``(e) Supplements.--
``(1) Supplemental applications.--
``(A) In general.--With respect to any of the
following changes related to a technology certification
order, a supplemental application to a technology
certification order shall be submitted by the holder of
the technology certification order describing such
proposed changes, and the in vitro clinical test with
such changes may not be introduced into interstate
commerce until a technology certification order for
such supplemental application is granted:
``(i) Any significant change to the
procedures provided in support of the
application for technology certification
submitted under subparagraph (G) or (H) of
subsection (c)(2).
``(ii) Any significant change to the
procedures provided in support of the
application for technology certification
submitted under subparagraph (F) of subsection
(c)(2).
``(B) Secretary action on supplemental
applications.--Any action by the Secretary on a
supplemental application shall be in accordance with
subsection (d), and any order resulting from such
supplement shall be treated as an amendment to a
technology certification order.
``(2) Content of application.--
``(A) In general.--A supplemental application for a
change to an in vitro clinical test under a technology
certification order shall--
``(i) contain all necessary information to
make a showing that any in vitro clinical test
affected by such change that is within the
scope of the technology certification order
will meet the applicable standard; and
``(ii) be limited to such information that
is needed to support the change.
``(B) Content.--Unless otherwise specified by the
Secretary, a supplemental application under this
subsection shall include--
``(i) a description of the change,
including a rationale for implementing such
change;
``(ii) a description of how the change was
evaluated;
``(iii) data from a representative in vitro
clinical test or tests that supports a showing
that, in using the modified procedure or
procedures, all eligible in vitro clinical
tests within the scope of the technology
certification will meet the applicable
standard;
``(iv) as applicable, information to
demonstrate that the modified procedure or
procedures submitted under subsection (c)(2)(F)
continue to conform to applicable requirements
under section 587K; and
``(v) any other information requested by
the Secretary.
``(3) Changes in response to a public health risk.--
``(A) In general.--If the holder of a technology
certification makes a change to an in vitro clinical
test or tests to address a potential risk to public
health by adding a new specification or test method,
such holder may immediately implement such change and
shall submit a notification for such change to the
Secretary within 30 days.
``(B) Content.--Any notification to the Secretary
under this paragraph shall include--
``(i) a summary of the relevant change;
``(ii) the rationale for implementing such
change;
``(iii)(I) if such a change necessitates a
change to the procedures reviewed as part of
the granted technology certification order, the
modified procedures; or
``(II) if the procedures were not changed,
an explanation as to why they were not changed;
and
``(iv) if such a change necessitates a
change to the procedures reviewed as part of
the granted technology certification order,
data from a representative in vitro clinical
test or tests that support a showing that, in
using the modified procedures, all eligible in
vitro clinical tests within the scope of the
technology certification will meet the
applicable standard.
``(f) Temporary Hold.--
``(1) In general.--Subject to the process specified in
paragraph (2), and based on one or more findings under
paragraph (4), the Secretary may issue a temporary hold
prohibiting any holder of a technology certification order
issued under this section from introducing into interstate
commerce an in vitro clinical test that was not previously the
subject of a listing under section 587J. The temporary hold
shall identify the grounds for the temporary hold under
paragraph (4) and the rationale for such finding.
``(2) Process for issuing a temporary hold.--If the
Secretary makes a finding that a temporary hold may be
warranted based on one or more grounds specified in paragraph
(4), the Secretary shall promptly notify the holder of the
technology certification order of such finding and provide 30
calendar days for the developer to come into compliance with or
otherwise resolve the finding.
``(3) Written requests.--Any written request to the
Secretary from the holder of a technology certification order
that a temporary hold under paragraph (1) be removed shall
receive a decision, in writing and specifying the reasons
therefore, within 90 days after receipt of such request. Any
such request shall include information to support the removal
of the temporary hold.
``(4) Grounds for temporary hold.--The Secretary may
initiate a temporary hold under this subsection upon a finding
that the holder of a technology certification order--
``(A) is not in compliance with the conditions of
the technology certification order pursuant to
subsection (b)(1)(D);
``(B) offers one or more in vitro clinical tests
with advertising or labeling that is false or
misleading;
``(C) has reported a correction or removal of an in
vitro clinical test that is offered under a technology
certification order under this section and has failed
to demonstrate that the issue or issues causing the
correction or removal does not adversely impact the
ability of other in vitro clinical tests offered under
the same technology certification order to meet the
applicable standard; or
``(D) has introduced into interstate commerce an in
vitro clinical test under a technology certification
order and such test is adulterated or misbranded, based
on a determination by the Secretary, and has failed to
demonstrate that the issue or issues causing the
adulteration or misbranding does not adversely impact
the ability of other in vitro clinical tests offered
under the same technology certification granted under
this section to meet the applicable standard.
``(g) Withdrawal.--The Secretary may, after due notice and
opportunity for an informal hearing, issue an order withdrawing a
technology certification order including all tests introduced into
interstate commerce under the technology certification order if the
Secretary finds that--
``(1) the application, supplement, or report under
subsection (h) contains false or misleading information or
fails to reveal a material fact;
``(2) such holder fails to correct false or misleading
labeling or advertising upon the request of the Secretary;
``(3) in connection with a technology certification, the
holder provides false or misleading information to the
Secretary; or
``(4) the holder of such technology certification order
fails to correct the grounds for a temporary hold within a
timeframe specified in the temporary hold order.
``(h) Reports to Congress.--
``(1) In general.--Not later than 1 year after the
effective date of the VALID Act of 2023, and annually
thereafter for the next 4 years, the Secretary shall submit to
the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives, and make publicly available, including through
posting on the website of the Food and Drug Administration, a
report containing the information described in paragraph (2).
``(2) Content.--
``(A) In general.--Each report under paragraph (1)
shall address, at a minimum--
``(i) the total number of applications for
technology certifications filed, issued,
withdrawn, and denied;
``(ii) the total number of technology
certification orders the Secretary put on
temporary hold under subsection (h) and the
number of technology certification orders
withdrawn under subsection (i);
``(iii) the types of technologies for which
the Secretary issued technology certification
orders;
``(iv) the total number of holders of
technology certification orders that are in
effect; and
``(v) the total number of in vitro clinical
test categories that required premarket review
under section 587B that were redesignated as
eligible in vitro clinical tests under this
section.
``(B) Final report.--The fifth report submitted
under paragraph (1) shall include a summary of, and
responses to, comments raised in the docket.
``(C) Performance reports.--The reports required
under this section may be issued with performance
reports as required under section 9 of the VALID Act of
2023.
``(i) Public Meeting and Input.--
``(1) Public docket.--Not later than 30 days after the date
of enactment of the VALID Act of 2023, the Secretary shall
establish a public docket to receive comments concerning
recommendations for implementation of this section, including
criteria and procedures for subsections (c) through (h). The
public docket shall remain open for at least 1 year after the
establishment of the public docket.
``(2) Public meeting.--Not later than 180 days after the
date of enactment of the VALID Act of 2023, the Secretary shall
convene a public meeting to which stakeholders from
organizations representing patients and consumers, academia,
and the in vitro clinical test industry are invited to discuss
the technology certification process including application
requirements, inspections, alignment with third-party
accreditors, and the definition of the term `technology' under
section 587.
``(j) Regulations.--The Secretary shall issue regulations regarding
the technology certification process, including describing criteria or
procedures relating to technology certification under this section,
which shall be subject to public comment for a minimum of 60 days from
issuance prior to finalizing such regulations after considering the
comments received. The regulation shall include an outline of the
application process, opportunities to meet with officials of the Food
and Drug Administration, and plans to streamline inspections.
``(k) Notification.--
``(1) In general.--Notwithstanding subsection (a)(1), a
first-of-a-kind in vitro clinical test or a combination product
that meets the definition of a moderate-risk test under section
587 may be introduced into interstate commerce under a
technology certification order that has been issued by the
Secretary, subject to other applicable requirements if--
``(A) the developer provides notification to the
Secretary 60 days prior to introducing such tests into
interstate commerce that includes information
demonstrating that the test is moderate-risk and within
the scope of the applicable technology certification
order; and
``(B) the Secretary has not issued a notification
to the developer under paragraph (2) before such time
has elapsed.
``(2) Notification from secretary.--The Secretary shall
issue a notification to the developer that such test may not be
introduced into interstate commerce under such order if the
Secretary determines that--
``(A) such test--
``(i) does not meet the definition of a
moderate-risk test under section 587;
``(ii) is not eligible to be introduced
into interstate commerce under any of
subparagraphs (A) through (E) of subsection
(a)(1); or
``(iii) is not eligible to be introduced
into interstate commerce under the referenced
technology certification order issued by the
Secretary because it is not within the scope of
the technology certification order under
subsection (b)(2); or
``(B) based on the information included in the
notification submitted by the developer pursuant to
this subsection, there is insufficient information for
the Secretary to make the determinations described in
clauses (i), (ii), and (iii) of subparagraph (A).
``SEC. 587E. MITIGATING MEASURES.
``(a) Establishment of Mitigating Measures.--
``(1) Establishing, changing, or withdrawing.--
``(A) Establishment.--The Secretary may establish
and require, on the basis of evidence, mitigating
measures for any in vitro clinical test or category of
in vitro clinical tests with the same indications for
use that is introduced or delivered for introduction
into interstate commerce after the Secretary
establishes any such mitigating measures.
``(B) Methods of establishment.--The Secretary may
establish mitigating measures--
``(i) under the process set forth in
subparagraph (D);
``(ii) as provided under section 587F; or
``(iii) through a premarket approval or
technology certification order, which may
establish mitigating measures for an individual
in vitro clinical test or a category of in
vitro clinical tests.
``(C) Methods of change or withdrawal.--The
Secretary may change or withdraw mitigating measures--
``(i) under the process set forth in
subparagraph (D); or
``(ii) as provided under section 587F.
``(D) Process for establishment, change, or
withdrawal.--Notwithstanding subchapter II of chapter 5
of title 5, United States Code, the Secretary may, upon
the initiative of the Secretary or upon petition of an
interested person, establish, change, or withdraw
mitigating measures for an in vitro clinical test or
category of in vitro clinical tests by--
``(i) publishing a proposed order in the
Federal Register;
``(ii) providing an opportunity for public
comment for a period of not less than 30 60
calendar days; and
``(iii) after consideration of any comments
submitted, publishing a final order in the
Federal Register that responds to the comments
submitted, and which shall include a reasonable
transition period.
``(E) Effect of mitigating measures on
grandfathered tests.--A mitigating measure shall not be
required by the Secretary for an in vitro clinical test
subject to section 587G(a).
``(2) In vitro clinical tests previously cleared or exempt
as devices with special controls.--
``(A) In general.--Any special controls applicable
to an in vitro clinical test previously cleared or
exempt under section 510(k), or classified under
section 513(f)(2) prior to date of enactment of the
VALID Act of 2023, including any such special controls
established during the period beginning on the date of
enactment of the VALID Act of 2023 and ending on the
effective date of such Act (as described in section
5(b) of such Act)--
``(i) shall continue to apply to such in
vitro clinical test after such effective date;
and
``(ii) are deemed to be mitigating measures
as of the effective date specified in section
5(a)(1)(A) of the VALID Act of 2023.
``(B) Changes.--Notwithstanding subparagraph (A),
the Secretary may establish, change, or withdraw
mitigating measures for such tests or category of tests
using the procedures under paragraph (1).
``(b) Documentation.--
``(1) In vitro clinical tests subject to premarket
review.--The developer of an in vitro clinical test subject to
premarket review under section 587B and to which mitigating
measures apply shall maintain documentation in accordance with
the applicable quality requirements under section 587K and make
such documentation available to the Secretary upon request or
inspection.
``(2) Other tests.--The developer of an in vitro clinical
test that is offered under a technology certification order or
other exemption from premarket review under section 587B and to
which mitigating measures apply shall--
``(A) maintain documentation in accordance with the
applicable quality requirements under section 587K
demonstrating that such mitigating measures continue to
be met following a test modification by the developer;
``(B) make such documentation available to the
Secretary upon request or inspection; and
``(C) include in the performance summary for such
test a brief description of how such mitigating
measures are met, if applicable.
``SEC. 587F. REGULATORY PATHWAY DESIGNATION.
``(a) Pathway Determinations.--
``(1) In general.--After considering available evidence
with respect to an in vitro clinical test or category of in
vitro clinical tests with the same intended use, including the
identification, establishment under paragraph (4), and
implementation of mitigating measures under section 587E, as
appropriate, the Secretary may, upon the initiative of the
Secretary or upon request of a developer, determine that--
``(A) such in vitro clinical test is high-risk and
subject to premarket review under section 587B;
``(B) such in vitro clinical tests, including a
first-of-a-kind test, is moderate-risk and subject to
abbreviated premarket review under section 587B(b) or
technology certification under section 587D(a)(1); or
``(C) such in vitro clinical test, including a
first-of-a-kind test is low-risk or otherwise exempt
from premarket review under section 587B.
``(2) Requests.--
``(A) Submissions by developers.--
``(i) Abbreviated premarket review;
technology certification.--A developer
submitting a request that the Secretary make a
determination as described in paragraph (1)(B)
shall submit information to support that the in
vitro clinical test is moderate-risk or propose
mitigating measures, if applicable, that would
support such a determination.
``(ii) Low-risk; exempt from premarket
review.--A developer submitting a request that
the Secretary make a determination as described
in paragraph (1)(C) shall submit information
that the in vitro clinical test is low-risk, or
otherwise appropriate for exemption from
premarket review under section 587B and propose
mitigating measures, if applicable, that would
support such a determination.
``(B) Response by the secretary.--Not later than 30
days after receiving a request under clause (i) or (ii)
of subparagraph (A), the Secretary shall provide a
timely response describing whether or not the Secretary
will initiate the process for making a determination
under paragraph (1)(B) or (1)(C) as described in
paragraph (4).
``(3) Sufficiency of mitigating measures.--When determining
whether mitigating measures for an in vitro clinical test, or
category of in vitro clinical tests, are sufficient to make
such test moderate-risk or low-risk, the Secretary shall take
into account the following:
``(A) The degree to which the technology for the
intended use of the in vitro clinical test is well-
characterized, taking into consideration factors that
include one or more of the following:
``(i) Peer-reviewed literature.
``(ii) Practice guidelines.
``(iii) Consensus standards.
``(iv) Recognized standards of care.
``(v) Use of such technology, including
historical use.
``(vi) Multiple scientific publications by
different authors.
``(vii) Adoption by the scientific or
clinical community.
``(viii) Real world evidence.
``(B) Whether the criteria for performance of the
test are well-established to be sufficient for the
intended use.
``(C) The clinical circumstances under which the in
vitro clinical test is used, including whether the in
vitro clinical test is the sole determinate for the
diagnosis or treatment of the targeted disease, and the
availability of other tests (such as confirmatory or
adjunctive tests) or relevant material standards.
``(D) Whether such mitigating measures sufficiently
mitigate the risk of harm such that the test or
category of tests is moderate-risk or low-risk.
``(4) Process.--
``(A) In general.--For a test that is not first-of-
a-kind, any action under paragraph (1) shall be made by
publication of a notice of such proposed action on the
website of the Food and Drug Administration, the
consideration of comments to a public docket on such
proposal, and publication of a final action on such
website within 60 calendar days of the close of the
comment period posted to such public docket,
notwithstanding subchapter II of chapter 5 of title 5,
United States Code.
``(B) Process for first-of-a-kind test.--In the
case of an in vitro clinical test that is first-of-a-
kind, the process is as follows:
``(i) Any determination that the test is
subject to premarket approval or abbreviated
premarket review under subparagraph (A) or (B)
of paragraph (1) shall be published on the
website of the Food and Drug Administration,
notwithstanding subclause II of chapter 5 of
title 5, United States Code, only after the in
vitro clinical test is approved under section
587B. Until that time, the determination shall
not be binding on other in vitro clinical
tests.
``(ii) Any determination other than those
made under clause (i) shall be made by
publication of a notice of final action on the
website of the Food and Drug Administration,
notwithstanding subchapter II of chapter 5 of
title 5, United States Code.
``(5) No effect on grandfathering determinations.--A
determination under paragraph (1) shall have no effect on the
applicability of section 587G to an in vitro clinical tests.
``(b) Transition Period.--Upon a decision by the Secretary to
change a regulatory pathway designation, or reclassifies an in vitro
clinical test, or category of in vitro clinical tests, the Secretary
shall provide an appropriate transition period with respect to any new
requirements.
``(c) Appeals.--A decision by the Secretary under this section
shall be deemed a significant decision subject to appeal under section
587P.
``(d) Advisory Committee.--The Secretary may request
recommendations from an advisory committee under section 587H pursuant
to carrying out this section.
``(e) Request for Informal Feedback.--Before submitting a premarket
application or technology certification application for an in vitro
clinical test--
``(1) the developer of the test may submit to the Secretary
a written request for a meeting, conference, or written
feedback to discuss and provide information relating to the
regulation of such in vitro clinical test which may include--
``(A) the submission process and the type and
amount of evidence expected to demonstrate the
applicable standard;
``(B) which regulatory pathway is appropriate for
an in vitro clinical test; and
``(C) an investigation plan for an in vitro
clinical test, including a clinical protocol; and
``(2) upon receipt of such a request, the Secretary shall--
``(A) if a meeting is requested--
``(i) within 60 calendar days after such
receipt, or within such time period as may be
agreed to by the developer, meet or confer with
the developer submitting the request; and
``(ii) within 15 calendar days after such
meeting or conference, provide to the developer
a written record or response describing the
issues discussed and conclusions reached in the
meeting or conference; and
``(B) if written feedback is requested, provide
feedback to the requestor within 75 days after such
receipt.
``SEC. 587G. GRANDFATHERED IN VITRO CLINICAL TESTS.
``(a) In General.--Subject to subsection (d), an in vitro clinical
test is exempt from the requirements of this subchapter specified in
subsection (b) if--
``(1) the test was first offered for clinical use, and was
not intended solely for investigational use, not later than 45
days after the date of enactment of the VALID Act of 2023;
``(2) the test was developed by a clinical laboratory for
which a certificate was in effect under section 353 of the
Public Health Service Act that meets the requirements for
performing tests of high complexity;
``(3) the test is performed--
``(A) in the same clinical laboratory in which the
test was developed for which a certification is still
in effect under section 353 of the Public Health
Service Act that meets the requirements to perform
tests of high complexity;
``(B) by another clinical laboratory for which a
certificate is in effect under section 353 of such Act
that meets the requirements to perform tests of high
complexity, and that is within the same corporate
organization and having common ownership by the same
parent corporation as the laboratory in which the test
was developed; or
``(C) in the case of a test that was developed by
the Centers for Disease Control and Prevention or
another laboratory in a public health laboratory
network coordinated or managed by the Centers for
Disease Control and Prevention, by a clinical
laboratory for which a certificate is in effect under
section 353 of such Act that meets the requirements to
perform tests of high complexity, and that is within a
public health laboratory network coordinated or managed
by the Centers for Disease Control and Prevention;
``(4) the test does not have in effect an approval under
section 515, a clearance under section 510(k), an authorization
under section 513(f)(2), or an exemption under section 520(m),
or licensure under section 351 of the Public Health Service
Act;
``(5) any modification to the test on or after the date
that is 45 days after the date of enactment of the VALID Act of
2023 is made by the initial developer, conforms with section
587C(a)(6)(A)(ii), and does not meet the criteria in subsection
(d)(1);
``(6) when used as an investigational in vitro clinical
test, such test complies with section 587S, as applicable;
``(7) the test is offered with an order from an authorized
person as required under section 353 of the Public Health
Service Act, and was offered with a prescription required under
section 809.30(f) of title 21, Code of Federal Regulations
prior to the effective date of this subchapter;
``(8) the test is not for use with home specimen
collection, unless the specimen is collected with a collection
container, receptacle, or kit that--
``(A) has been approved, cleared, or authorized by
the Secretary for home specimen collection and the
collection is performed pursuant to the approved,
cleared, or authorized labeling, including any
indication for use as prescription use or over-the-
counter use, or
``(B) is exempt from premarket review and its use
is consistent with applicable limitations on the
exemption;
``(9) the test is not a specimen receptacle or instrument;
``(10) each test report for the test bears a statement that
reads as follows: `This in vitro clinical test was introduced
into commerce prior to the application of the VALID Act and is
exempt from FDA premarket review.'; and
``(11) the developer of the test--
``(A) maintains documentation demonstrating that
the test meets and continues to meet the criteria set
forth in this subsection; and
``(B) makes such documentation available to the
Secretary upon request.
``(b) Exemptions Applicable to Grandfathered Tests.--An in vitro
clinical test that meets the criteria specified in subsection (a) is
exempt from premarket review under 587B, labeling requirements under
587L, and test design requirements and quality requirements under 587K,
and may be lawfully offered subject to the other applicable
requirements of this Act.
``(c) Modifications.--In the case of an in vitro clinical test that
meets the criteria specified in subsection (a), such test continues to
qualify for the exemptions described in subsection (b) if the test is
modified and the modification is of a type described in subsection
(a)(5), and the person modifying such in vitro clinical test--
``(1) documents each such modification and maintains
documentation of the basis for such determination;
``(2) provides such documentation relating to the change to
the Secretary upon request or inspection; and
``(3) does not modify the in vitro clinical test such that
it no longer meets the criteria under subsection (a).
``(d) Request for Information.--
``(1) Criteria.--The criteria described in this paragraph
are any of the following:
``(A) There is a lack of valid scientific evidence
to support that the in vitro clinical test is
analytically valid or clinically valid.
``(B) Such in vitro clinical test is being offered
by its developer with any false or misleading
analytical or clinical claims.
``(C) It is probable that such in vitro clinical
test will cause serious adverse health consequences.
``(2) Process.--
``(A) Written request for information.--The
Secretary may issue a written request to a developer
identifying specific scientific concerns, based on
credible information, with an in vitro clinical test,
which indicate that one or more of the criteria
described in paragraph (1) apply to such in vitro
clinical test. Such written request shall include
specific information requests pertaining to such
criteria.
``(B) Deadline for submitting information.--Not
later than 45 days after receiving a request for
information under subparagraph (A)--
``(i) the developer of an in vitro clinical
test--
``(I) may seek a teleconference
prior to the submission of information
under subclause (II) to discuss the
Secretary's request; and
``(II) shall submit the information
requested pursuant to subparagraph (A),
and may include in such submission a
request for a teleconference; and
``(ii) the Secretary shall--
``(I) schedule a teleconference
requested under clause (i)(I); and
``(II) hold a teleconference if
requested within 10 days of the
Secretary's receipt of the information
submitted under clause (i)(II).
``(C) Review deadline.--Upon receiving a submission
under subparagraph (B), the Secretary shall--
``(i) review the submitted information
within 45 calendar days of such receipt, which
may include communication with the developer;
and
``(ii) determine whether the criteria
listed in paragraph (1) apply to the in vitro
clinical test and communicate such
determination to the developer as described in
subparagraph (D).
``(D) Communication and results of determination.--
The Secretary shall notify the developer, in writing,
of the Secretary's determination under subparagraph
(C), as follows:
``(i) If the Secretary determines that none
of the criteria listed in paragraph (1) apply
to the in vitro clinical test, such test shall
be exempt from relevant requirements of this
subchapter, as set forth in subsection (b),
subject to the criteria under subsection (a).
``(ii) If the Secretary determines that one
or more of the criteria listed in paragraph (1)
apply to the test but such a determination may
be resolved within a reasonable time, and the
test has not been previously subject to this
subsection on the basis of the same or
substantially similar scientific concerns
identified in the written request issued under
paragraph (d)(2)(A)--
``(I) the Secretary shall notify
the developer of such a determination
and allow the developer to seek a
teleconference to discuss the finding;
``(II) the developer shall submit
information demonstrating resolution of
the determination within 15 days of
receiving such notification; and
``(III) the Secretary shall make a
determination within 30 days of the
receipt of such submission of
information as to whether the criteria
under paragraph (1) continue to apply
to the test and, if through such
determination the Secretary determines
that--
``(aa) none of the criteria
listed in paragraph (1) apply
to the test, such test shall be
exempt from relevant
requirements of the subchapter
as set forth in subsection (b),
subject to applicable
limitations; or
``(bb) one or more of the
criteria listed in paragraph
(1) apply to the in vitro
clinical test, such test is not
exempt as set forth in this
section and shall not be
offered unless approved under
section 587B, or, upon a
determination by the Secretary
pursuant to section 587F,
offered under a technology
certification order under
section 587D or offered as a
low-risk test.
``(iii) If the Secretary determines that
one or more of the criteria listed in paragraph
(1) apply to the in vitro clinical test and
clause (ii) does not apply, the in vitro
clinical test is not exempt as set forth in
this section and shall not be offered unless
approved under section 587B, or upon a
determination by the Secretary pursuant to
section 587F, offered under a technology
certification order under section 587D or
offered as a low-risk test.
``SEC. 587H. ADVISORY COMMITTEES.
``(a) In General.--The Secretary may establish advisory committees
or use advisory committee panels of experts established before the date
of enactment of the VALID Act of 2023 (including a device
classification panel under section 513) for the purposes of providing
expert scientific advice and making recommendations related to--
``(1) the approval of an application for an in vitro
clinical test submitted under this subchapter, including for
evaluating, as applicable, the analytical validity, clinical
validity, and safety of in vitro clinical tests;
``(2) the potential effectiveness of mitigating measures
for a determination of the applicable regulatory pathway under
section 587F(b) or risk evaluation for an in vitro clinical
test or tests;
``(3) quality requirements under section 587K or applying
such requirements to in vitro clinical tests developed or
imported by developers;
``(4) appeals under section 587P; or
``(5) such other purposes as the Secretary determines
appropriate.
``(b) Appointments.--
``(1) Voting members.--The Secretary shall appoint to each
committee established under subsection (a), as voting members,
individuals who are qualified by training and experience to
evaluate in vitro clinical tests referred to the committee for
the purposes specified in subsection (a), including individuals
with, to the extent feasible, scientific expertise in the
development of such in vitro clinical tests, laboratory
operations, and the use of in vitro clinical tests. The
Secretary shall designate one member of each committee to serve
as chair.
``(2) Nonvoting members.--In addition to the individuals
appointed pursuant to paragraph (1), the Secretary shall
appoint to each committee established under subsection (a), as
nonvoting members--
``(A) a representative of consumer interests; and
``(B) a representative of interests of in vitro
clinical test developers not directly affected by the
matter to be brought before the committee.
``(3) Limitation.--No individual who is a regular full-time
employee of the United States and engaged in the administration
of this Act may be a member of any advisory committee
established under subsection (a).
``(4) Education and training.--The Secretary shall, as
appropriate, provide education and training to each new
committee member before such member participates in a
committee's activities, including education regarding
requirements under this Act and related regulations of the
Secretary, and the administrative processes and procedures
related to committee meetings.
``(5) Meetings.--The Secretary shall ensure that scientific
advisory committees meet regularly and at appropriate intervals
so that any matter to be reviewed by such a committee can be
presented to the committee not more than 60 calendar days after
the matter is ready for such review. Meetings of the committee
may be held using electronic or telephonic communication to
convene the meetings.
``(6) Compensation.--Members of an advisory committee
established under subsection (a), while attending meetings or
conferences or otherwise engaged in the business of the
advisory committee--
``(A) shall be entitled to receive compensation at
rates to be fixed by the Secretary, but not to exceed
the daily equivalent of the rate in effect for
positions classified above level GS-15 of the General
Schedule; and
``(B) may be allowed travel expenses as authorized
by section 5703 of title 5, United States Code, for
employees serving intermittently in the Government
service.
``(c) Guidance.--The Secretary may issue guidance on the policies
and procedures governing advisory committees established under
subsection (a).
``SEC. 587I. BREAKTHROUGH IN VITRO CLINICAL TESTS.
``(a) In General.--The purpose of this section is to encourage the
Secretary, and provide the Secretary with sufficient authority, to
apply efficient and flexible approaches to expedite the development of,
and prioritize the review of, in vitro clinical tests that represent
breakthrough technologies.
``(b) Establishment of Program.--The Secretary shall establish a
program to expedite the development of, and provide for the priority
review of, in vitro clinical tests.
``(c) Eligibility.--The program developed under subsection (b)
shall be available for any in vitro clinical test that--
``(1) provides or enables more effective treatment or
diagnosis of life-threatening or irreversibly debilitating
human disease or conditions; and
``(2) is a test--
``(A) that represents a breakthrough technology;
``(B) for which no approved alternative in vitro
clinical test exists, including no in vitro clinical
test offered under a technology certification order;
``(C) that offers a clinically meaningful advantage
over existing alternative in vitro clinical tests that
are approved (including in vitro clinical tests offered
under a technology certification order), including the
potential to reduce or eliminate the need for
hospitalization, improve patient quality of life,
facilitate patients' ability to manage their own care
(such as through self-directed personal assistance), or
establish long-term clinical efficiencies; or
``(D) the availability of which is in the best
interest of patients or public health.
``(d) Designation.--
``(1) Request.--To receive breakthrough designation under
this section, an applicant may request that the Secretary
designate the in vitro clinical test for expedited development
and priority review. Any such request for designation may be
made at any time prior to, or at the time of, the submission of
an application under section 587B or 587D, and shall include
information demonstrating that the test meets the criteria
described in subsection (c).
``(2) Determination.--Not later than 60 calendar days after
the receipt of a request under paragraph (1), the Secretary
shall determine whether the in vitro clinical test that is the
subject of the request meets the criteria described in
subsection (c). If the Secretary determines that the test meets
the criteria, the Secretary shall designate the test for
expedited development and priority review.
``(3) Review.--Review of a request under paragraph (1)
shall be undertaken by a team that is composed of experienced
staff and senior managers of the Food and Drug Administration.
``(4) Withdrawal.--
``(A) In general.--The designation of an in vitro
clinical test under this subsection is deemed to be
withdrawn, and such in vitro clinical test shall no
longer be eligible for designation under this section,
if an application for approval for such test under
section 587B or 587D is denied. Such test shall be
eligible for breakthrough designation upon a new
request for such designation.
``(B) Exception.--The Secretary may not withdraw a
designation granted under this subsection based on the
subsequent approval or technology certification of
another in vitro clinical test that--
``(i) is designated under this section; or
``(ii) was given priority review under
section 515B.
``(e) Actions.--For purposes of expediting the development and
review of in vitro clinical tests under this section, the Secretary may
take the actions and additional actions set forth in paragraphs (1) and
(2), respectively, of section 515B(e) when reviewing such tests. Any
reference or authorization in section 515B(e) with respect to a device
shall be deemed a reference or authorization with respect to an in
vitro clinical test for purposes of this section.
``(f) Guidance.--Not later than 30 months after the date of
enactment of the VALID Act of 2023, the Secretary shall issue final
guidance on the implementation of this section. Such guidance shall--
``(1) set forth the process by which a person may seek a
designation under subsection (d);
``(2) provide a template for request under subsection (d);
``(3) identify the criteria the Secretary will use in
evaluating a request for designation; and
``(4) identify the criteria and processes the Secretary
will use to assign a team of staff, including team leaders, to
review in vitro clinical tests designated for expedited
development and priority review, including any training
required for such personnel to ensure effective and efficient
review.
``(g) Rules of Construction.--Nothing in this section shall be
construed to affect--
``(1) the criteria and standards for evaluating an
application pursuant to section 587B or 587D, including the
recognition of valid scientific evidence as described in
section 587(20) and consideration and application of the least
burdensome means described under section 587AA(c);
``(2) the authority of the Secretary with respect to
clinical holds under section 587S;
``(3) the authority of the Secretary to act on an
application pursuant to section 587B before completion of an
establishment inspection, as the Secretary determines
appropriate; or
``(4) the authority of the Secretary with respect to
postmarket surveillance under section 587X.
``SEC. 587J. REGISTRATION AND LISTING.
``(a) Registration Requirement.--
``(1) In general.--Each person described in subsection
(b)(1) shall--
``(A) during the period beginning on October 1 and
ending on December 31 of each year, register with the
Secretary the name of such person, places of business
of such person, all establishments engaged in the
activities specified under this paragraph, the
establishment registration number of each such
establishment, and a point of contact for each such
establishment, including an electronic point of
contact; and
``(B) submit an initial registration containing the
information required under subparagraph (A)--
``(i) in accordance with the timelines for
submission under subsection (c), if the
establishment is engaged in any activity
described in subsection (b)(1) on the effective
date of this section, unless the Secretary
establishes by guidance a date later than such
date for all or a category of such
establishments; or
``(ii) not later than 30 days prior to
engaging in any activity described in
subsection (b)(1), if the establishment is not
engaged in any activity described in this
paragraph on the effective date of this
section.
``(2) Registration numbers.--The Secretary may assign a
registration number to any person or an establishment
registration number to any establishment registered in
accordance with this section. Registration information shall be
made publicly available by publication on the website
maintained by the Food and Drug Administration, in accordance
with subsection (d).
``(3) Inspection.--Each person or establishment that is
required to be registered with the Secretary under this section
shall be subject to inspection pursuant to section 704.
``(b) Listing Information for In Vitro Clinical Tests.--
``(1) In general.--Each person who--
``(A) is a developer; and
``(B) introduces or proposes to begin the
introduction or delivery for introduction into
interstate commerce through an exemption under
subsection (a)(1), (a)(2), (a)(3), or (g) of section
587C or section 587G or through the filing of an
application under section 587B or section 587D,
shall submit a listing to the Secretary containing the
information described in paragraph (2), or (4), as applicable,
in accordance with the applicable schedule described under
subsection (c). Such listing shall be prepared in such form and
manner as the Secretary may specify in guidance. Listing
information shall be submitted through the comprehensive test
information system in accordance with section 587T, as
appropriate.
``(2) Submissions.--Each developer submitting a listing
under paragraph (1) shall electronically submit to the
comprehensive test information system described in section 587T
the following information, as applicable, for each in vitro
clinical test for which such person is a developer in the form
and manner prescribed by the Secretary, taking into account the
least burdensome requirements under section 587AA(c):
``(A) Name of the establishment and its
establishment registration number.
``(B) Contact information for the official
correspondent for the listing.
``(C) Name (common name and trade name, if
applicable) of the in vitro clinical test and its test
listing number (when available).
``(D) The certificate number for any laboratory
certified by the Secretary under section 353 of the
Public Health Service Act that meets the requirements
to perform high-complexity testing and that is the
developer of the in vitro clinical test, and the
certificate number under such section for any
laboratory that is performing the test, is within the
same corporate organization, and has common ownership
by the same parent corporation.
``(E) Whether the in vitro clinical test is, as
applicable, offered as a test approved under section
587B, offered under a granted technology certification
order, or offered as an exempt in vitro clinical test
under section 587C or 587G.
``(F) Indications for use information under section
587(10).
``(G) A brief summary of the analytical and
clinical performance of the in vitro clinical test, and
as applicable, the lot release criteria.
``(H) A brief description of conformance with any
applicable mitigating measures, restrictions, and
standards.
``(I) Representative labeling for the in vitro
clinical test, as appropriate.
``(3) Test listing number.--The Secretary may assign a test
listing number to each in vitro clinical test that is the
subject of a listing under this section. The process for
assigning test listing numbers may be established through
guidance, and may include the recognition of standards,
formats, or conventions developed by a third-party
organization.
``(4) Grandfathered tests.--A developer offering a test
that is a grandfathered in vitro clinical test under section
587G(a) shall submit listing information required under
subparagraphs (A) through (F) of paragraph (2), and may submit
a statement of the performance specifications for such in vitro
clinical tests.
``(5) Exempt tests.--A developer of an in vitro clinical
test who introduces or proposes to begin the introduction or
delivery for introduction into interstate commerce that is
otherwise exempt from the requirement to submit listing
information pursuant to an exemption under section 587C may
submit listing information under this subsection.
``(c) Timelines for Submission of Listing Information.--
``(1) In general.--The timelines for submission of
registration and listing under subsections (a) and (b) are as
follows:
``(A) For an in vitro clinical test that was listed
as a device under section 510(j) prior to the effective
date of this section, a person shall maintain a device
listing under section 510 until such time as the system
for submitting the listing information required under
subsection (b) becomes available and thereafter shall
submit the listing information not later than the later
of 1 year after the system for submitting the listing
under this section becomes available or the effective
date of this section.
``(B) For an in vitro clinical test that is subject
to grandfathering under section 587G(a) a person shall
submit the listing information required under
subsection (b)(4) within 10 calendar days of offering
the test after the effective date of this section.
``(C) For an in vitro clinical test that is not
described in subparagraph (A) or (B), a person shall
submit the required listing information as follows:
``(i) For an in vitro clinical test that is
not exempt from premarket approval under
section 587B, a person shall submit the
required listing information, prior to offering
the in vitro clinical test and not later than
30 business days after the date of approval of
the premarket approval application.
``(ii) For an in vitro clinical test that
is exempt from premarket review under section
587C, the required listing information shall be
submitted prior to offering the in vitro
clinical test.
``(2) Updates.--
``(A) Updates after changes.--Each developer
required to submit listing information under this
section shall update such information within 10
business days of any change that causes any previously
listed information to be inaccurate or incomplete.
``(B) Annual updates.--Each developer required to
submit listing information under this section shall
update its information annually during the period
beginning on October 1 and ending on December 31 of
each year.
``(d) Public Availability of Listing Information.--
``(1) In general.--Listing information submitted pursuant
to this section shall be made publicly available on the website
of the Food and Drug Administration in accordance with
paragraph (3).
``(2) Confidentiality.--Listing information for an in vitro
clinical test that is subject to premarket approval or
technology certification shall remain confidential until such
date as the in vitro clinical test receives the applicable
premarket approval or the developer receives a technology
certification order and for subsequent tests introduced under a
technology certification order until their introduction.
``(3) Exceptions from public availability requirements.--
The public listing requirements of this subsection shall not
apply to any registration and listing information submitted
under subsection (a) or (b), if the Secretary determines that
such information--
``(A) is a trade secret or confidential commercial
or financial information; or
``(B) if posted, could compromise national
security.
``(e) Submission of Information by Accredited Persons.--If agreed
upon by the developer, the information required under this section may
be submitted by a person accredited under section 587Q.
``SEC. 587K. TEST DESIGN AND QUALITY REQUIREMENTS.
``(a) Applicability.--
``(1) In general.--Each developer shall establish and
maintain quality requirements in accordance with the applicable
requirements set forth in subsection (b).
``(2) Certified laboratory requirements.--A developer shall
establish and maintain quality requirement under subsection
(b)(2) or (b)(3), as applicable, if such developer is a
clinical laboratory certified by the Secretary under section
353 of the Public Health Service Act that--
``(A) is certified to perform high-complexity
testing;
``(B) develops an in vitro clinical test that is
for use only--
``(i) within the laboratory certified by
the Secretary under such section 353 in which
such test was developed; or
``(ii) within another laboratory certified
by the Secretary under such section 353 if such
laboratory is--
``(I) within the same corporate
organization and has common ownership
by the same parent corporation as the
laboratory in which the test was
developed; or
``(II) within a public health
laboratory network coordinated or
managed by the Centers for Disease
Control and Prevention, if the test is
developed by a public health laboratory
or the Centers for Disease Control and
Prevention; and
``(C) does not manufacture, produce, or distribute
in vitro clinical tests other than laboratory test
protocols.
``(3) Regulations.--The Secretary shall promulgate quality
system regulations implementing this section. In promulgating
such regulations under this section, the Secretary shall
consider whether, and to what extent, international
harmonization is appropriate.
``(4) Quality systems for hybrid developers of both
laboratory test protocols and other in vitro clinical tests.--
An entity that develops both laboratory test protocols and
other in vitro clinical tests shall comply with subsection
(b)(1) for activities related to the development of any in
vitro clinical test that is not a laboratory test protocol and
with subsection (b)(2) or (b)(3), as applicable, for activities
related to the development of any laboratory test protocol.
``(b) Quality Requirements.--
``(1) In general.--The quality requirements applicable
under this section shall--
``(A) avoid duplication of regulations and guidance
under section 353 of the Public Health Service Act,
such that laboratories would not be subject to
conflicting regulatory obligations with respect to the
same activity;
``(B) not apply to laboratory operations; and
``(C) include, as applicable, subject to
subparagraphs (A) and (B) and paragraphs (2) and (3)--
``(i) management responsibilities;
``(ii) quality audits;
``(iii) personnel;
``(iv) design controls;
``(v) document controls;
``(vi) purchasing controls;
``(vii) identification and traceability;
``(viii) production and process controls;
``(ix) acceptance activities;
``(x) nonconforming in vitro clinical
tests;
``(xi) corrective and preventive action;
``(xii) labeling and packaging controls;
``(xiii) handling, storage, distribution,
and installation;
``(xiv) complaints and records;
``(xv) servicing; and
``(xvi) statistical techniques.
``(2) Exception for laboratory test protocols.--Developers
that are developing test protocols for use as described in
subsection (a)(2)(B)(i) are exempt from the requirements under
paragraph (1)(C) except for the requirements described in
clauses (iv), (ix), (xi), and (xiv) of such paragraph.
``(3) Quality requirements for certain laboratories
distributing laboratory test protocols within organizations or
public health networks.--Quality requirements applicable to the
developer who is distributing a laboratory test protocol as
described in subsection (a)(2)(B)(ii) shall consist of the
following:
``(A) Clauses (iv), (ix), (xi), (xiv), (xii) of
paragraph (1)(B).
``(B) The requirement to maintain records of the
laboratories to which the laboratory test protocol is
distributed.
``(c) Regulations.--In implementing quality requirements for test
developers that participate in international audit programs under this
section, the Secretary shall--
``(1) for purposes of facilitating international
harmonization, consider whether the developer participates in
an international audit program in which the United States
participates and recognizes compliance with, or conformance to,
such standards recognized by the Secretary; and
``(2) ensure a least burdensome approach described in
section 587AA(c) by leveraging, to the extent applicable, the
quality assurance requirements applicable to developers
certified by the Secretary under section 353 of the Public
Health Service Act.
``SEC. 587L. LABELING REQUIREMENTS.
``(a) In General.--An in vitro clinical test shall bear or be
accompanied by labeling, as applicable, that meets the requirements set
forth in subsections (b) and (c), unless such test is exempt under
subsection (d) or (e).
``(b) Labels.--
``(1) In general.--The label of an in vitro clinical test,
shall meet the requirements set forth in paragraph (2) if there
is an immediate container to which the label is applied.
``(2) Regulations.--The label of an in vitro clinical test
shall state the name and place of business of its developer and
meet the requirements set forth in regulations promulgated in
accordance with this section.
``(c) Labeling.--
``(1) In general.--Labeling of an in vitro clinical test,
including labeling in the form of a package insert, website,
standalone laboratory reference document, or other similar
document shall include--
``(A) adequate directions for use and shall meet
the requirements set forth in regulations promulgated
under this section, except as provided in subsection
(d) or (e); and
``(B) the information described in paragraph (2),
as applicable.
``(2) Content.--Labeling of an in vitro clinical test shall
include--
``(A) the test listing number that was provided to
the developer at the time of listing;
``(B) information to facilitate reporting an
adverse event;
``(C) information regarding accessing the
performance summary data displayed in the listing
database for the test;
``(D) the indications for use of the in vitro
clinical test; and
``(E) any warnings, contraindications, or
limitations.
``(3) Public availability of information.--The Secretary
shall make all of the information described in paragraph (2)
with respect to each in vitro clinical test available to the
public, as applicable, in accordance with section 587T, except
to the extent that the Secretary determines that such
information--
``(A) is trade secret or confidential commercial or
financial information; or
``(B) if posted, could compromise national
security.
``(4) Additional requirements.--Labeling for an in vitro
clinical test used for immunohematology testing shall meet the
applicable requirements set forth in part 660 of title 21, Code
of Federal Regulations (or any successor regulations), related
to the labeling of blood grouping reagents, reagent red blood
cells, and anti-human globulin.
``(d) Exemptions and Alternative Requirements.--
``(1) In general.--
``(A) In general.--With respect to an in vitro
clinical test that meets the criteria of subparagraph
(B), the `state in one place' regulations under section
809.10(b) of title 21, Code of Federal Regulations (or
any successor regulations) may be satisfied by the
laboratory posting such information on its website or
in multiple documents, if such documents are maintained
and accessible in one place.
``(B) Applicable tests.--An in vitro clinical test
meets the criteria of this subparagraph if such test
is--
``(i) developed by a laboratory certified
by the Secretary under section 353 of the
Public Health Service Act that meets the
requirements to perform tests of high-
complexity; and
``(ii) performed in--
``(I) the same laboratory in which
such test was developed; or
``(II) by another laboratory
certified by the Secretary under
section 353 of the Public Health
Service Act that--
``(aa) meets the
requirements to perform tests
of high complexity; and
``(bb) is under common
ownership and control as the
laboratory that developed the
test.
``(2) Test instrument labeling.--Unless the instrument is
the entire test system, the labeling for an instrument is not
required to bear the information indicated in paragraphs (3),
(4), (5), (7), (8), (9), (10), (11), (12), and (13) of section
809.10(b) of title 21, Code of Federal Regulations (or any
successor regulations).
``(3) Reagent labeling.--For purposes of compliance with
subsection (c)(1), the labeling for a reagent intended for use
as a replacement in an in vitro clinical test may be limited to
that information necessary to identify the reagent adequately
and to describe its proper use in the test.
``(4) Investigational use.--A shipment or other delivery of
an in vitro clinical test for investigational use pursuant to
section 587S shall be exempt from the labeling requirements of
subsections (b) and (c)(1) and from any standard promulgated
through regulations, except as required under section 353 of
the Public Health Service Act or section 587R of this Act.
``(5) General purpose laboratory reagents.--The labeling of
general purpose laboratory reagents (such as hydrochloric acid)
whose uses are generally known by persons trained in their use
need not bear the directions for use required by subsection
(c)(1)(A).
``(6) Over-the-counter test specimen receptacle labeling.--
The labeling for over-the-counter test specimen receptacles for
drugs of abuse testing shall bear the name and place of
business of the developer included in the registration under
section 587J and any information specified in applicable
regulations promulgated under this section, in language
appropriate for the intended users.
``(e) Tests in the Strategic National Stockpile.--
``(1) In general.--The Secretary may grant an exception or
alternative to any provision listed in this section, unless
explicitly required by a statutory provision outside this
subchapter, for specified lots, batches, or other units of an
in vitro clinical test, if the Secretary determines that
compliance with such labeling requirement could adversely
affect the availability of such products that are, or will be,
included in the Strategic National Stockpile under section
319F-2 of the Public Health Service Act.
``(2) Regulations.--The Secretary may issue regulations
amending section 809.11 of title 21, Code of Federal
Regulations (or any successor regulation) to apply in full or
in part to in vitro clinical tests and in vitro clinical test
developers.
``(f) Regulations.--The Secretary shall issue regulations related
to standardized, general content and format for in vitro clinical test
labeling pursuant to this subsection.
``SEC. 587M. ADVERSE EVENT REPORTING.
``(a) In General.--Each in vitro clinical test developer shall
establish and maintain a system for establishing and maintaining
records of adverse events and reporting adverse events in accordance
with this section.
``(b) Submission of Individual Reports.--A developer shall submit
an individual adverse event report not later than 5 calendar days after
the developer receives or becomes aware of an adverse event that
reasonably suggests that an in vitro clinical test may--
``(1) have caused or contributed to a patient or user
death; or
``(2) present an imminent threat to public health.
``(c) Submission of Quarterly Reports.--As applicable, a developer
shall submit quarterly reports that include any in vitro clinical test
errors and serious injuries that occurred during the applicable
quarter. Such quarterly reports shall be submitted not later than the
end of the quarter following the quarter in which the developer
receives or becomes aware of such adverse events.
``(d) Definitions.--For the purposes of this section--
``(1) the term `in vitro clinical test error' means a
failure of an in vitro clinical test to meet its performance
specifications, or to otherwise perform as intended by the
developer, including an inaccurate result resulting from such
failure; and
``(2) the term `serious injury' means--
``(A) a significant delay in a diagnosis that
results in the absence, delay, or discontinuation of
critical medical treatment or that irreversibly or
seriously and negatively alters the course of a disease
or condition; or
``(B) an injury that--
``(i) is life threatening;
``(ii) results in permanent impairment of a
body function or permanent damage to a body
structure; or
``(iii) necessitates medical or surgical
intervention to preclude permanent impairment
of a body function or permanent damage to a
body structure.
``(e) Regulations.--The Secretary shall promulgate regulations to
implement this section.
``SEC. 587N. CORRECTIONS AND REMOVALS.
``(a) Regulations.--The Secretary shall promulgate regulations, or
amend existing regulations, as appropriate, to implement this section.
``(b) Reports of Corrections and Removals.--
``(1) In general.--Each in vitro clinical test developer
shall report to the Secretary any correction or removal of an
in vitro clinical test undertaken by such developer if the
correction or removal was undertaken--
``(A) to reduce the risk to health posed by the in
vitro clinical test; or
``(B) to remedy a violation of this Act caused by
the in vitro clinical test which may present a risk to
health.
``(2) Exception for in vitro clinical tests offered under a
technology certification order.--For any eligible test offered
under a technology certification order under section 587D, a
correction and removal report for any correction or removal of
an in vitro clinical test should demonstrate that the issue or
issues causing the correction or removal do not adversely
impact the ability of other in vitro clinical tests offered
under the same technology certification order to meet the
applicable standard.
``(c) Timing.--A developer shall submit any report required under
this subsection to the Secretary within 15 business days of initiating
such correction or removal.
``(d) Recordkeeping.--A developer of an in vitro clinical test that
undertakes a correction or removal of an in vitro clinical test which
is not required to be reported under this subsection shall keep a
record of such correction or removal.
``(e) Recall Communications.--Upon the reporting of a correction or
removal by the developer--
``(1) the Secretary shall classify such correction or
removal under this section within 45 calendar days; and
``(2) not later than 70 calendar days after the developer
or other responsible party notifies the Secretary that it has
completed a recall action, the Secretary shall provide the
developer or other responsible party with a written statement
closing the recall action or stating the reasons the Secretary
cannot close the recall at that time.
``SEC. 587O. RESTRICTED IN VITRO CLINICAL TESTS.
``(a) Applicability.--
``(1) In general.--For the types of in vitro clinical tests
described in paragraph (3), the Secretary may require, in
issuing an approval of an in vitro clinical test under section
587B, granting a technology certification order under section
587D, or in issuing a determination under section 587F(a), or
by issuing a regulation, that such test, or category of tests,
be restricted to sale, distribution, or use upon such
conditions as the Secretary may prescribe under paragraph (2).
``(2) Conditions.--The Secretary may prescribe conditions
under this section, based on available evidence, with respect
to an in vitro clinical test described in paragraph (3), that
are determined to be needed due to the potential for harmful
effect of such test (including any resulting absence,
significant delay, or discontinuation of appropriate medical
treatment), and are necessary to ensure that the test meets the
applicable standard.
``(3) In vitro clinical tests subject to restrictions.--The
restrictions or conditions authorized under this section may be
applied by the Secretary to any high-risk or moderate-risk in
vitro clinical test, prescription home-use in vitro clinical
test, direct-to-consumer in vitro clinical test, or over-the-
counter in vitro clinical test.
``(b) Labeling and Advertising of a Restricted in Vitro Clinical
Test.--The labeling and advertising of an in vitro clinical test to
which restrictions apply under subsection (a) shall bear such
appropriate statements of the restrictions as the Secretary may
prescribe in an approval under section 587B, an order under section
587D, a determination under section 587F(a), or in regulation, as
applicable.
``(c) Device Restrictions.--An in vitro clinical test that was
offered as a restricted device prior to the date of enactment of this
subchapter--
``(1) shall continue to comply with the applicable
restrictions under section 515 or section 520(e) until this
subchapter takes effect; and
``(2) except for in vitro clinical tests required to meet
the requirements of section 809.30 of title 21, Code of Federal
Regulations prior to the effective date of this subchapter
specified in section 5(a)(1)(A) of the VALID Act of 2023, such
restrictions described in paragraph (1) shall be deemed to be
restrictions under this subchapter as of such effective date.
``SEC. 587P. APPEALS.
``(a) Significant Decision.--
``(1) In general.--The Secretary shall--
``(A) maintain a substantive summary of the
scientific and regulatory rationale for any significant
decision of the Food and Drug Administration pursuant
to section 587F, regarding--
``(i) the submission of an application for,
or a review of, an in vitro clinical test under
section 587B or section 587D;
``(ii) an exemption under section 587C; or
``(iii) any requirements for mitigation
measures to an in vitro clinical test or
category of in vitro clinical tests; and
``(B) include in such summaries documentation of
significant controversies or differences of opinion and
the resolution of such controversies or differences of
opinion.
``(2) Provision of documentation.--Upon request, the
Secretary shall furnish a substantive summary described in
paragraph (1) to the person who has made, or is seeking to
make, a submission described in such paragraph.
``(3) Application of least burdensome requirements.--The
substantive summary required under this subsection shall
include a brief statement regarding how the least burdensome
requirements were considered and applied consistent with
section 587AA(c), as applicable.
``(b) Review of Significant Decisions.--
``(1) Request for supervisory review of significant
decision.--A developer may request a supervisory review of the
significant decision described in subsection (a)(1). Such
review may be conducted at the next supervisory level or higher
above the agency official who made the significant decision.
``(2) Submission of request.--A developer requesting a
supervisory review under paragraph (1) shall submit such
request to the Secretary not later than 30 days after the
decision for which the review is requested and shall indicate
in the request whether such developer seeks an in-person
meeting or a teleconference review.
``(3) Timeframe.--The Secretary shall schedule an in-person
or teleconference review, if so requested, not later than 30
days after such request is made. The Secretary shall issue a
decision to the developer requesting a review under this
subsection not later than 45 days after the request is made
under paragraph (1), or, in the case of a developer who
requests an in-person meeting or teleconference, 30 days after
such meeting or teleconference.
``(c) Advisory Panels.--The process established under subsection
(a) shall permit the appellant to request review by an advisory
committee established under section 587G when there is a dispute
involving substantial scientific fact. If an advisory panel meeting is
held, the Secretary shall make a determination under this subsection
not later than 45 days after the requested advisory committee meeting
has concluded.
``(d) Least Burdensome Review.--Any developer who has submitted an
application under section 587B or 587D may request a supervisory review
of a request for additional information during an evaluation of such
submission within 60 calendar days of receipt of the additional
information request from the Secretary.
``(e) Availability of All Remedies.--The procedures set forth in
this section shall be in addition to, and not in lieu of, other
remedies available to the developer.
``SEC. 587Q. ACCREDITED PERSONS.
``(a) In General.--
``(1) Authorization.--Beginning on the date of enactment of
the VALID Act of 2023, the Secretary shall accredit persons for
any of the following purposes:
``(A) Reviewing applications for premarket approval
under section 587B and making findings with respect to
such applications.
``(B) Reviewing applications for technology
certification under section 587D and making
recommendations to the Secretary with respect to such
applications.
``(C) Conducting inspections as specified in
subsection (c) of in vitro clinical test developers and
other persons required to register pursuant to section
587J.
``(2) Persons submitting applications.--A person submitting
an application for premarket approval under section 587B or an
application for technology certification under section 587D may
submit such application to the Secretary or to a person
accredited pursuant to subparagraph (A) or (B) of paragraph
(1).
``(b) Accredited Persons Application Reviews, Findings, and
Recommendations.--
``(1) Requirements for premarket application.--
``(A) Review, finding, and recommendation
requirements.--An accredited person receiving an
application for premarket approval under section 587B
shall either--
``(i) provide to the Secretary, together
with the application for premarket approval
submitted by the applicant, a recommendation
based on a finding that the criteria for
approval of the application under section
587B(e)(2)(A) are met and issue a copy of such
finding to the applicant, which finding shall
plainly state--
``(I) the basis for the accredited
person's finding that the criteria
under section 587B(e)(2)(A) are met;
and
``(II) any proposed restrictions,
mitigating measures, or conditions of
approval under section 587B(e)(2)(B),
as applicable; or
``(ii) provide a notification to the
applicant that the accredited person cannot
find that the criteria for approval of the
application under section 587B(e)(2)(A) are met
and the reasons for such decision.
``(B) Requesting missing or clarifying
information.--After receipt of an application from an
accredited person under this section, the Secretary may
request missing or clarifying information from the
applicant concerning the application, which the
accredited person shall promptly provide.
``(C) Secretary action on recommendation that
approval criteria are met.--If the accredited person
transmits a recommendation to the Secretary under
subparagraph (A)(i), then prior to the date that is 45
calendar days after the transmittal date, the Secretary
shall consider such recommendation and make a
determination to--
``(i) approve the application for premarket
approval under section 587B(e)(2) with
appropriate restrictions, mitigating measures,
or conditions of approval, as applicable; or
``(ii) deny approval of the application by
issuing a written notice that reflects
appropriate management input and concurrence to
the accredited person and the applicant
detailing the scientific basis for the
Secretary's determination that the criteria for
issuance of an approval under section
587B(e)(2)(A) have not been met.
``(D) Effect of inaction on recommendation.--If the
Secretary fails to take an action under subparagraph
(C) the Secretary shall--
``(i) within 45 calendar days after the
transmittal date, provide written feedback to
the applicant that--
``(I) includes all outstanding
issues with the application preventing
the Secretary from taking an action
under subparagraph (B);
``(II) reflects appropriate
management input and concurrence; and
``(III) includes action items for
the Secretary, the applicant, or both,
as appropriate, with an estimated date
of completion for the Secretary and the
applicant to complete their respective
tasks, as applicable; and
``(ii) promptly schedule a meeting or
teleconference to discuss the feedback provided
under clause (i), unless the Secretary and
applicant agree that the outstanding issues are
adequately presented through written
correspondence and a meeting or teleconference
is not necessary.
``(2) Requirements for technology certification.--
``(A) Review and recommendation requirements.--An
accredited person receiving an application for
technology certification under section 587D shall
either--
``(i) provide to the Secretary, together
with the application for technology
certification submitted by the applicant, a
recommendation that the criteria for issuance
of a technology certification order under
section 587D(d)(3) are met and issue a copy of
such recommendation to the applicant, which
recommendation shall plainly state the basis
for the accredited person's recommendation that
the criteria under section 587D(d)(3) are met;
or
``(ii) provide a notification to the
applicant that the accredited person cannot
recommend that the criteria for issuance of a
technology certification order under section
587D(d)(3) are met and the reasons for such
decision.
``(B) Requesting missing or clarifying
information.--After receipt of an application under
this section, the accredited person may request missing
or clarifying information from the applicant concerning
the application, which the applicant shall promptly
provide.
``(C) Secretary action on recommendation for
issuance of a technology certification order.--If the
accredited person transmits a recommendation to the
Secretary under clause (i) of subparagraph (A), then
prior to the date that is 60 calendar days after the
transmittal date the Secretary shall--
``(i) issue the technology certification
order under section 587D(d)(3), consistent with
such recommendation from the accredited person;
or
``(ii) deny approval of the application by
issuing a written notice to the accredited
person and the applicant detailing the
scientific basis for a determination by the
Secretary that the criteria for issuance of a
technology certification order under section
587D(d)(3) have not been met.
``(c) Requirements for Inspections.--
``(1) In general.--When conducting inspection, persons
accredited under subsection (a)(1)(C) shall record in writing
their specific observations and shall present their
observations to the designated representative of the inspected
establishment.
``(2) Inspection report requirements.--Each person
accredited under subsection (a)(1)(C) shall prepare and submit
to the Secretary an inspection report in a form and manner
designated by the Secretary for conducting inspections. Any
statement or representation made by an employee or agent of an
establishment to a person accredited to conduct inspections
under subsection (a)(1)(C) shall be subject to section 1001 of
title 18, United States Code.
``(3) Savings clause.--Nothing in this section affects the
authority of the Secretary to inspect any in vitro clinical
test developer or other person registered under section 587J or
recognize inspections conducted by auditing organizations as
described under section 704(g)(15).
``(4) Inspection limitations.--The Secretary shall ensure
that inspections carried out under this section are not
duplicative of inspections carried out under section 353 of the
Public Health Service Act. Inspections under this section shall
be limited to the data and information necessary--
``(A) for routine surveillance activities of
facilities associated with an approved application
under section 587B or issuance of a technology
certification order under section 587D; or
``(B) to meet the requirements for premarket
approval under section 587B or issuance of a technology
certification order under section 587D, as applicable.
``(d) Accreditation.--
``(1) Accreditation program.--The Secretary may provide for
accreditation under this section through programs administered
by the Food and Drug Administration, by other non-Federal
government agencies, or by qualified nongovernmental
organizations. A person may be accredited for the review of
applications submitted under sections 587B as described in
subsection (a)(1)(A), for the review of applications submitted
under section 587D as described in subsection (a)(1)(B), and to
conduct inspection activities under subsection (a)(1)(C), or
for a subset of such reviews or activities.
``(2) Eligible persons.--
``(A) Minimum qualifications.--An accredited
person, at a minimum, shall--
``(i) not be an employee of the Federal
Government;
``(ii) not engage in the activities of a
developer, as defined in section 587(7);
``(iii) not be a person required to
register under section 587J, unless such person
has established sufficient processes and
protocols to separate activities to develop in
vitro clinical tests and the activities for
which such person would be accredited under
subsection (a) and discloses applicable
information under this section;
``(iv) not be owned or controlled by, and
shall have no organizational, material, or
financial affiliation with, an in vitro
clinical test developer or other person
required to register under section 587J;
``(v) be a legally constituted entity
permitted to conduct the activities for which
it seeks accreditation;
``(vi) ensure that the operations of such
person are in accordance with generally
accepted professional and ethical business
practices; and
``(vii) include in its request for
accreditation a commitment to, at the time of
accreditation and at any time it is performing
activities pursuant to this section--
``(I) certify that the information
reported to the Secretary accurately
reflects the data or protocol reviewed,
and the documented inspection findings,
as applicable;
``(II) limit work to that for which
competence and capacity are available;
``(III) treat information received
or learned, records, reports, and
recommendations as proprietary
information of the person submitting
such information; and
``(IV) in conducting the activities
for which the person is accredited in
respect to a particular in vitro
clinical test, protect against the use
of any employee or consultant who has a
financial conflict of interest
regarding that in vitro clinical test.
``(B) Waiver.--The Secretary may waive any
requirements in clause (i), (ii), (iii), or (iv) of
subparagraph (A) upon making a determination that such
person has implemented other appropriate controls
sufficient to ensure a competent and impartial review.
``(3) Accreditation process.--
``(A) Accreditation process guidance and
regulations.--Not later than 180 days after the date of
enactment of the VALID Act of 2023, the Secretary shall
issue draft guidance specifying the process for
submitting a request for accreditation and
reaccreditation under this section, including the form
and content of information to be submitted, including
the criteria that the Secretary will consider to
accredit or deny accreditation and, not later than 1
year after the close of the comment period for the
draft guidance, issue final guidance.
``(B) Response to request.--The Secretary shall
respond to a request for accreditation or
reaccreditation within 60 calendar days of the receipt
of the request. The Secretary's response may be to
accredit or reaccredit the person, to deny
accreditation, or to request additional information in
support of the request. If the Secretary requests
additional information, the Secretary shall respond
within 60 calendar days of receipt of such additional
information to accredit or deny the accreditation.
``(C) Type of accreditation.--The accreditation or
reaccreditation of a person shall specify the
particular activity or activities under subsection (a)
for which such person is accredited, and shall include
any limitation to certain eligible in vitro clinical
tests.
``(D) Public list.--The Secretary shall publish on
the website of the Food and Drug Administration a list
of persons who are accredited under this section. Such
list shall be updated on at least a monthly basis. The
list shall specify the particular activity or
activities under this section for which the person is
accredited.
``(E) Audit.--The Secretary may audit the
performance of persons accredited under this section
for purposes of ensuring that such persons continue to
meet the published criteria for accreditation, and may
modify the scope or particular activities for which a
person is accredited if the Secretary determines that
such person fails to meet one or more criteria for
accreditation.
``(F) Suspension or withdrawal.--The Secretary may
suspend or withdraw accreditation of any person
accredited under this section, after providing notice
and an opportunity for an informal hearing, when such
person is substantially not in compliance with the
requirements of this section or the published criteria
for accreditation, or poses a threat to public health,
or fails to act in a manner that is consistent with the
purposes of this section.
``(G) Reaccreditation.--Accredited persons may be
initially accredited for up to 3 years. After
expiration of such initial period, persons may be
reaccredited for unlimited additional 5-year periods,
as determined by the Secretary.
``(e) Compensation of Accredited Persons.--Compensation of an
accredited person shall be determined by agreement between the
accredited person and the person who engages the services of the
accredited person, and shall be paid by the person who engages such
services.
``(f) International Harmonization.--Notwithstanding any other
provision of this section, to facilitate international harmonization
the Secretary may recognize persons accredited or recognized by
governments, who have also entered into information sharing agreements,
including confidentiality commitments, with the Commissioner of Food
and Drugs.
``(g) Information Sharing Agreements.--An accredited person may
enter into an agreement with a test developer to provide information to
the comprehensive test information system under section 587T, including
any requirements under section 587J.
``(h) Reports.--Not later than 2 years after the effective date of
the VALID Act of 2023, and annually thereafter for the next 4 years,
the Secretary shall post on the website of the Food and Drug
Administration, a report describing the Secretary's performance in
implementing this section, including the Secretary's progress in
minimizing duplicative reviews of applications for which an accredited
person finds the criteria for approval are met. Such reports shall
include, for each period--
``(1) with regard to premarket approval applications--
``(A) the total number of findings transmitted to
the Secretary under subsection (b)(1)(A)(i);
``(B) the total number of determinations made by
the Secretary under subsection (b)(1)(B)(i) within 30
calendar days of the transmittal date to approve an
application;
``(C) the total number of determinations made by
the Secretary under subsection (b)(1)(B)(ii) within 30
calendar days of the transmittal date to deny approval
of an application; and
``(D) the total number of applications that were
approved and the total number of applications that were
denied approval, after the Secretary failed to make a
determination within 30 calendar days of the
transmittal date under subsection (b)(1)(B); and
``(2) with regard to applications for technology
certification--
``(A) the total number of recommendations
transmitted to the Secretary under subsection
(b)(2)(A)(i);
``(B) the total number of determinations made by
the Secretary under subsection (b)(2)(B)(i) to issue a
technology certification order, including
determinations made within 30 days of the transmittal
date;
``(C) the total number of determinations made by
the Secretary under subsection (b)(2)(B)(ii) to deny
the application for technology certification, including
determinations made within 30 calendar days of the
transmittal date; and
``(D) the total number of technology certification
orders issued, and the total number of applications for
technology certification that were denied, including
applications denied after the Secretary failed to make
a determination within 30 calendar days of the
transmittal date under subsection (b)(2)(B).
``SEC. 587R. RECOGNIZED STANDARDS.
``(a) In General.--The Secretary may recognize all or part of
appropriate standards established by nationally or internationally
recognized standards development organizations for which a person may
submit a declaration of conformity in order to meet a requirement under
this subchapter to which that standard is applicable. Standards for in
vitro diagnostic devices previously recognized under section 514(c)
shall be considered recognized standards under this section. Recognized
and proposed standards shall be accessible to the public at no charge.
The application of any such consensus standard shall only apply
prospectively. The Secretary shall issue regulations establishing the
criteria and process, for such recognition and adoption.
``(b) Amendment Process.--The procedures established in this
section or in regulation or guidance issued under this section shall
apply to amendment of an existing standard.
``SEC. 587S. INVESTIGATIONAL USE.
``(a) In General.--Subject to the conditions prescribed in
subsections (c), (d), (e), (f), and (g), an in vitro clinical test for
investigational use shall be exempt from the requirements of this
subchapter, other than sections 587A, 587P, 587T, and 587V. The
Secretary may amend parts 50, 54, and 56 of title 21 of the Code of
Federal Regulations to apply to in vitro clinical tests to permit the
investigational use of such tests by experts qualified by scientific
training and experience.
``(b) Regulations.--
``(1) In general.--Not later than 3 years after the date of
enactment of the VALID Act of 2023, the Secretary shall
promulgate regulations to implement this section.
``(2) Variation.--The requirements in the regulations
promulgated under this section shall take into account
variations based on--
``(A) the scope and duration of clinical testing to
be conducted under investigation that is the subject of
such application;
``(B) the number of human subjects that are to be
involved in such testing;
``(C) the need to permit changes to be made to the
in vitro clinical test involved during testing
conducted in accordance with a plan required under
subsection (c)(6); or
``(D) whether the clinical testing of such in vitro
clinical test is for the purpose of developing data to
obtain approval to offer such test.
``(c) Application for Investigational Use.--The following shall
apply with respect to in vitro clinical tests for investigational use:
``(1) Significant risk and other studies.--In the case of
an in vitro clinical test the investigational use of which
poses a significant risk to the human subject or involves an
exception from informed consent for emergency research, a
sponsor of an investigation of such a test seeking an
investigational use exemption shall submit to the Secretary an
investigational use application with respect to the in vitro
clinical test in accordance with paragraphs (3) and (4).
``(2) Non-significant risk studies.--In the case of an in
vitro clinical test, the investigational use of which is not
described in paragraph (1)--
``(A) the sponsor of such investigation shall--
``(i) ensure such investigation is
conducted in compliance with an investigational
plan approved by an institutional review
committee and the labeling of the in vitro
clinical test involved clearly and
conspicuously states, `For investigational use
only', as specified in paragraph (4)(A)(ii);
``(ii) ensure each investigator obtains
informed consent as required under part 50, 54,
and 56 of title 21, Code of Federal Regulations
(or any successor regulations), subject to the
exceptions set forth in paragraph (6)(C);
``(iii) establish and maintain records with
respect to all requirements in this
subparagraph;
``(iv) maintain records and make reports as
required by the Secretary pursuant to
regulations issued under subsection (b); and
``(v) ensure that investigators monitor
investigations, maintain records and make
reports as required by the Secretary pursuant
to regulations issued under subsection (b); and
``(B) the sponsor may rely on any exception or
exemption described in paragraph (4) or as established
by the Secretary in regulations issued under subsection
(b).
``(3) Application.--An investigational use application
shall be submitted in such time and manner and contain such
information as the Secretary may require in regulation, and
shall include an investigational plan for proposed clinical
testing and assurances that the sponsor submitting the
application will--
``(A) establish and maintain records relevant to
the investigation of such in vitro clinical test; and
``(B) submit to the Secretary annual reports of
data obtained as a result of the investigational use of
the in vitro clinical test during the period covered by
the exemption that the Secretary reasonably determines
will enable the Secretary--
``(i) to ensure compliance with the
conditions for the exemption specified in
paragraph (4);
``(ii) to review the progress of the
investigation involved; and
``(iii) to evaluate the ability to meet the
applicable standard.
``(4) Conditions for exemption.--An application for an
investigational use exemption with respect to a significant
risk study shall be granted if each of the following conditions
is met:
``(A) The risks to the subjects of the in vitro
clinical test are outweighed by the anticipated
benefits of the test to the subjects and the importance
of the knowledge to be gained, and adequate assurance
of informed consent is provided in accordance with
paragraphs (6)(B) and (6)(C).
``(B) The proposed labeling for the in vitro
clinical test involved clearly and conspicuously states
`For investigational use only'.
``(C) Such other requirements the Secretary
determines--
``(i) are necessary for the protection of
the public health and safety; and
``(ii) do not unduly delay investigation.
``(5) Coordination with investigational new drug
applications.--Any requirement for the submission of a report
to the Secretary pursuant to an application for an
investigational new drug exemption involving an in vitro
clinical test shall supersede the reporting requirement under
paragraph (3)(B), but only to the extent the requirement with
respect to the application for exemption with respect to the
drug is duplicative of the reporting requirement under such
paragraph.
``(6) Investigational plan, procedures, and conditions.--
With respect to an investigational plan submitted under
paragraph (3), the sponsor submitting such plan shall--
``(A) promptly notify the Secretary of the approval
or the suspension or termination of the approval of
such plan by an institutional review committee;
``(B) in the case of an in vitro clinical test made
available to investigators for clinical testing, obtain
agreements from each investigator that any testing of
the in vitro clinical test involving human subjects
will be under such investigator's supervision and in
accordance with paragraph (C) and submit such
agreements to the Secretary that ensure--
``(i) all investigators will comply with
this section, regulations promulgated or
revised under this section, and applicable
human subjects regulations; and
``(ii) the investigator will ensure that--
``(I) informed consent is obtained
as required under part 50 of title 21,
Code of Federal Regulations (or any
successor regulations), amended to
apply to in vitro clinical tests; and
``(II) the requirements for
institutional review board under part
56 of title 21 of the Code of Federal
Regulations (or successor regulations),
amended to apply to in vitro clinical
tests, are met; and
``(C) ensure that informed consent will be obtained
from each human subject (or the representative of such
subject) of proposed clinical testing involving such in
vitro clinical test, except where, subject to such
other conditions as the Secretary may prescribe--
``(i) the proposed clinical testing poses
no more than minimal risk to the human subject
and includes appropriate safeguards to protect
the rights, safety, and welfare of the human
subject; or
``(ii) the investigator conducting or
supervising the clinical testing determines in
writing that there exists a life-threatening
situation involving the human subject of such
testing which necessitates the use of such in
vitro clinical test and it is not feasible to
obtain informed consent from the subject and
there is not sufficient time to obtain such
consent from a representative of such subject.
``(7) Concurred by licensed physician.--The determination
required by paragraph (6)(C)(ii) shall be concurred in writing
by a licensed physician who is not involved in the testing of
the human subject with respect to which such determination is
made unless immediate use of the in vitro clinical test is
required to save the life of the human subject of such testing
and there is not sufficient time to obtain such concurrence.
``(8) Significant risk.--For purposes of this subsection,
the term `significant risk' means, with respect to an in vitro
clinical test, that the use of such in vitro clinical test--
``(A) is of substantial importance in performing an
activity or activities described in section 201(ss)(1)
for, a serious or life-threatening disease or condition
without confirmation of the diagnosis by a medically
established diagnostic product or procedure;
``(B) requires an invasive sampling procedure that
presents a significant risk to the human subject,
provided that routine venipuncture shall not be
considered an invasive sampling procedure; or
``(C) otherwise presents a potential for serious
risk to the health of a human subject.
``(d) Review of Applications.--
``(1) In general.--The Secretary may issue an order
approving an investigation as proposed, approving it with
conditions or modifications, or disapproving it.
``(2) Failure to act.--Unless the Secretary, not later than
30 calendar days after the date of the submission of an
application for an investigational use exemption that meets the
requirements of subsection (c), issues an order under paragraph
(1) and notifies the sponsor submitting the application, the
application shall be treated as approved as of such date
without further action by the Secretary.
``(3) Denial.--The Secretary may deny an investigational
use application submitted under this subsection if the
Secretary determines that the investigation with respect to
which the application is submitted does not conform to the
requirements of subsection (c). A notification of such denial
submitted to the sponsor with respect to such a request shall
contain the order of disapproval and a complete statement of
the reasons for the Secretary's denial of the application.
``(e) Withdrawal of Exemption.--
``(1) In general.--The Secretary may, by administrative
order, withdraw an exemption approved under this section with
respect to an in vitro clinical test, including an exemption
treated as approved based on the Secretary's failure to act
pursuant to subsection (d)(2), if the Secretary determines that
an investigation conducted under such an exemption does not
meet the applicable conditions under subsection (c)(3) for such
exemption.
``(2) Opportunity to be heard.--
``(A) In general.--Subject to subparagraph (B), an
order withdrawing an investigational use exemption
granted under this section may be issued only after the
Secretary provides the sponsor of the in vitro clinical
test with an opportunity for an informal hearing.
``(B) Exception.--An order referred to in
subparagraph (A) with respect to an investigational use
exemption granted under this section may be issued on a
preliminary basis before the provision of an
opportunity for an informal hearing if the Secretary
determines that the continuation of testing under the
exemption will result in an unreasonable risk to the
public health. The Secretary will provide an
opportunity for an informal hearing promptly following
any preliminary action under this subparagraph.
``(f) Changes.--
``(1) In general.--The regulations promulgated under
subsection (b) shall provide, with respect to an in vitro
clinical test for which an exemption under this subsection is
in effect, procedures and conditions under which changes are
allowed without the additional approval of an application for
an exemption or submission of a supplement to such an
application. Such regulations shall provide that such a change
may be made if--
``(A) the sponsor determines, on the basis of
credible information (as defined in regulations) that
the change meets the conditions specified in paragraph
(2); and
``(B) the sponsor submits to the Secretary, not
later than 5 calendar days after making the change, a
notice of the change.
``(2) Conditions.--The conditions specified in this
paragraph are that--
``(A) in the case of developmental changes to an in
vitro clinical test, including manufacturing changes,
the changes--
``(i) do not constitute a significant
change in design or in basic principles of
operation;
``(ii) do not affect the rights, safety, or
welfare of the human subjects involved in the
investigation; and
``(iii) are made in response to information
gathered during the course of an investigation;
and
``(B) in the case of changes to clinical protocols
applicable to the test, the changes do not affect--
``(i) the validity of data or information
resulting from the completion of an approved
clinical protocol, or the relationship of
likely patient risk to benefit relied upon to
approve a product;
``(ii) the scientific soundness of a plan
submitted under subsection (c)(3); or
``(iii) the rights, safety, or welfare of
the human subjects involved in the
investigation.
``(g) Clinical Hold.--
``(1) In general.--At any time, the Secretary may impose a
clinical hold with respect to an investigation of an in vitro
clinical test if the Secretary makes a written determination
described in paragraph (2). The Secretary shall, in imposing
such clinical hold, specify the basis for the clinical hold,
including the specific information available to the Secretary
which served as the basis for such clinical hold, and confirm
such determination in writing. The applicant may immediately
appeal any such determination pursuant to section 587P.
``(2) Determination.--
``(A) In general.--For purposes of paragraph (1), a
determination described in this subparagraph with
respect to a clinical hold is a determination that,
based on credible evidence, the in vitro clinical test
involved represents an unreasonable risk to the safety
of the persons who are the subjects of the clinical
investigation, taking into account the qualifications
of the clinical investigators, information about the in
vitro clinical test, the design of the clinical
investigation, the condition for which the in vitro
clinical test is to be investigated, and the health
status of the subjects involved.
``(B) Removal of clinical hold.--Any written
request to the Secretary from the sponsor of an
investigation that a clinical hold be removed shall
receive a decision, in writing and specifying the
reasons therefor, within 30 days after receipt of such
request. Any such request shall include sufficient
information to support the removal of such clinical
hold.
``SEC. 587T. COMPREHENSIVE TEST INFORMATION SYSTEM.
``(a) Establishment.--Not later than 2 years after the date of
enactment of the VALID Act of 2023, the Secretary shall make available
a comprehensive test information system for in vitro clinical tests
that is designed to--
``(1) provide a transparent interface on the website of the
Food and Drug Administration for stakeholders, to the extent
permitted by applicable law, which may include access to the--
``(A) regulatory pathway designation information
for each in vitro clinical test or tests with the same
indications for use;
``(B) registration and listing information provided
by developers under section 587J, including the use of
a link for labels;
``(C) adverse event reports submitted under section
587M, as appropriate;
``(D) reports of corrections and removals submitted
under section 587N; and
``(E) other information pertaining to an in vitro
clinical test or tests with the same indications for
use, as the Secretary determines appropriate; and
``(2) provide a secure portal for electronic submission,
including applications and other in vitro clinical test
submissions, registration and listing information, and adverse
event reports, which provides protections from unauthorized
disclosure of information, including of--
``(A) trade secret or confidential commercial or
financial information; and
``(B) information that could compromise national
security.
``(b) Submission Function.--The comprehensive test information
system shall serve as the electronic submission service for test
developers submitting information for applications under sections 587B
and 587D.
``SEC. 587U. PREEMPTION.
``(a) In General.--Except as provided in subsection (b), no State,
Tribal, or local government (or political subdivision thereof) may
establish or continue in effect any requirement--
``(1) that is different from, or in addition to, any
requirement applicable to an in vitro clinical test under this
Act; or
``(2) with respect to the analytical validity, clinical
validity, or safety for individuals who come into contact with
such an in vitro clinical test.
``(b) Exceptions.--Subsection (a) shall not be construed to affect
the authority of a State, Tribal, or local government to do any of the
following:
``(1) To license laboratory personnel, health care
practitioners, or health care facilities or to regulate any
aspect of a health care practitioner-patient relationship.
``(2) To enforce laws of general applicability, such as
zoning laws, environmental laws, labor laws, and general
business laws.
``(3) To authorize laboratories to develop and perform an
in vitro clinical test, pursuant to a law enacted by a State
prior to January 1, 2022, as long as such law does not impose
requirements that are different from any requirement applicable
to an in vitro clinical test under this Act. If a State has
enacted such a law, the Secretary shall exempt such test for
laboratories in that State from compliance with this
subchapter.
``(c) Clarification.--Nothing in this section shall be construed
to--
``(1) modify any action for damages or the liability of any
person under the law of any State; or
``(2) shift liability to health care practitioners or other
users.
``SEC. 587V. ADULTERATION.
``An in vitro clinical test shall be deemed to be adulterated:
``(1) If it consists in whole or in part of any filthy,
putrid, or decomposed substance.
``(2) If it has been developed, prepared, packed, or held
under insanitary conditions whereby it may have been
contaminated with filth, or whereby it may have been rendered
injurious to health.
``(3) If its container or package is composed, in whole or
in part, of any poisonous or deleterious substance which may
render the contents injurious to health.
``(4) If it bears or contains, for purposes of coloring
only, a color additive which is unsafe within the meaning of
section 721(a).
``(5) If its analytical or clinical validity, as
applicable, or with respect to a specimen receptacle, its
safety, falls below that which it purports or is represented to
possess.
``(6) If it is required to be, declared to be, purports to
be, or is represented as being, in conformity with any
performance standard established or recognized under section
587R and is not in conformity with such standard.
``(7) If it is required to be in compliance with mitigating
measures established under section 587E and is not in
conformity with such mitigating measures.
``(8) If it fails to have in effect an approved premarket
application under section 587B, unless such in vitro clinical
test is in compliance with the requirements for--
``(A) offering without an approved premarket
application under section 587D(b)(1);
``(B) an exemption from premarket approval under
section 587C or 587G; or
``(C) investigational use pursuant to section 587S.
``(9) If it is not in conformity with any condition
established under section 587B or 587D.
``(10) If it purports to be an in vitro clinical test
subject to an exemption under section 587C and it fails to meet
or maintain any criteria, condition, or requirement of such
exemption.
``(11) If it has been granted an exemption under section
587S for investigational use, and the person granted such
exemption or any investigator who uses such in vitro clinical
test under such exemption fails to comply with a requirement
prescribed by or under such section.
``(12) If it fails to meet the quality requirements
prescribed in or established under section 587K (as
applicable), or the methods used in, or facilities or controls
used for, its development, packaging, storage, or installation
are not in conformity with applicable requirements established
under such section.
``(13) If it has been developed, processed, packaged, or
held in any establishment, factory, or warehouse and the owner,
operator or agent of such establishment, factory, or warehouse
delays, denies, or limits an inspection, or refuses to permit
entry or inspection.
``(14) If it is not in compliance with any restriction
required under section 587O.
``SEC. 587W. MISBRANDING.
``An in vitro clinical test shall be deemed to be misbranded:
``(1) If its labeling is false or misleading in any
particular.
``(2) If in a package form unless it bears a label
containing--
``(A) the name and place of business of the test
developer, packager, or distributor; and
``(B) an accurate statement of the quantity of
contents in terms of weight, measure, or numerical
count, unless an exemption is granted by the Secretary
by the issuance of guidance, such as with respect to
small packages.
``(3) If any word, statement, or other information required
by or under authority of this Act to appear on the label or
labeling, including a test report, is not prominently placed
thereon with such conspicuousness (as compared with other
words, statements, designs, or devices, in the labeling) and in
such terms as to render it likely to be read and understood by
the ordinary individual under customary conditions of purchase
and use.
``(4) Unless its labeling bears adequate directions for use
and such adequate warnings as are necessary for the protection
of users of the in vitro clinical test and recipients of the
results of such in vitro clinical test, including patients,
consumers, donors, and related health care professionals.
Required labeling for in vitro clinical tests intended for use
in health care facilities, blood establishments, or by a health
care professional may be made available solely by electronic
means, provided that the labeling complies with all applicable
requirements of law, and that the test developer, or
distributor affords such users the opportunity to request the
labeling in paper form, and after such request, promptly
provides the requested information without additional cost.
``(5) If there is a reasonable probability that it could
cause serious or adverse health consequences or death,
including through absence, delay, or discontinuation in
diagnosis or treatment, when used in the manner prescribed,
recommended, or suggested in the labeling thereof.
``(6) If it was developed, sterilized, packaged,
repackaged, relabeled, installed, or imported in an
establishment not duly registered under section 587J or it was
not included in a listing under section 587J, in accordance
with timely reporting requirements under this subchapter.
``(7) In the case of any in vitro clinical test subject to
restrictions under section 587O, (1) if its advertising is
false or misleading in any particular, (2) if it is offered for
clinical use, sold, distributed, or used in violation of such
restrictions, or (3) unless the test developer or distributor
includes in all advertisements and other descriptive printed
matter that such person issues or causes to be issued, a brief
statement of the indications for use of the in vitro clinical
test and relevant warnings, precautions, side effects, and
contraindications. This paragraph shall not be applicable to
any printed matter that the Secretary determines to be labeling
as defined in section 201(m).
``(8) If it is subject to a mitigating measure established
under section 587E and does not bear such labeling as may be
prescribed in such mitigating measure.
``(9) If it is subject to a standard established under
section 587R and it does not bear such labeling as may be
prescribed in such standard.
``(10) Unless it bears such labeling as may be required by
or established under an applicable labeling requirement under
this Act.
``(11) If there was a failure to comply with any
requirement prescribed in or under section 587D, 587J, 587K,
587L, 587M, 587N, 587X, 587Y, 587Z, or to provide any report,
material, or other information required with respect to in
vitro clinical tests under this subchapter.
``SEC. 587X. POSTMARKET SURVEILLANCE.
``(a) In General.--
``(1) In general.--In addition to other applicable
requirements under this Act, the Secretary may issue an order
requiring a developer of a high-risk or moderate-risk in vitro
clinical test to conduct postmarket surveillance of such in
vitro clinical test, if the failure of the in vitro clinical
test is reasonably likely to result in serious adverse health
consequences or death from use of such in vitro clinical test.
``(2) Consideration.--In determining whether to require a
developer to conduct postmarket surveillance of an in vitro
clinical test, the Secretary shall take into consideration the
benefits and risks for the patient and the least burdensome
requirements under section 587AA(c).
``(b) Surveillance Approval.--
``(1) In general.--Each developer required to conduct
surveillance of an in vitro clinical test shall submit, within
30 days of receiving an order from the Secretary, a plan for
the required surveillance. The Secretary, within 60 days of the
receipt of such plan, shall determine if the person designated
to conduct the surveillance has the appropriate qualifications
and experience to undertake such surveillance and if the plan
will result in useful data that can reveal unforeseen adverse
events or other information necessary to protect the health of
patients or the public.
``(2) Timeline.--The developer shall commence surveillance
under this section not later than 15 months after the day on
which the Secretary orders such postmarket surveillance, unless
the Secretary determines more time is needed to commence
surveillance.
``(3) Prospective surveillance.--The Secretary may order a
prospective surveillance period of up to 3 years. Any
determination by the Secretary that a longer period is
necessary shall be made by mutual agreement between the
Secretary and the developer or, if no agreement can be reached,
upon the completion of a dispute resolution process pursuant to
section 562.
``SEC. 587Y. ELECTRONIC FORMAT FOR SUBMISSIONS.
``(a) In General.--All submissions to the Food and Drug
Administration with respect to an in vitro clinical test, unless
otherwise agreed to by the Secretary, shall--
``(1) be made electronically; and
``(2) with respect to the information required under
sections 587B and 587D, utilize the system described in section
587T.
``(b) Electronic Format.--Beginning on such date as the Secretary
specifies in final guidance issued under subsection (c), submissions
for in vitro clinical tests, including recommendations submitted by
accredited and recognized persons under section 587Q, and any appeals
of action taken by the Secretary with respect to such submissions,
shall be submitted in such electronic format as specified by the
Secretary in such guidance.
``(c) Guidance.--The Secretary shall issue guidance implementing
this section. Such guidance may--
``(1) provide standards for the electronic submission
required under subsection (a) or the submission in electronic
format required under subsection (b);
``(2) set forth criteria for waivers of, or exemptions
from, the requirements of subsection (a) or (b); and
``(3) provide any other information for the efficient
implementation and enforcement of this section.
``SEC. 587Z. POSTMARKET REMEDIES.
``(a) Safety Notice.--
``(1) In general.--If the Secretary determines that an in
vitro clinical test presents an unreasonable risk of
substantial harm to the public health, and notification under
this subsection is necessary to eliminate the unreasonable risk
of such harm and no more practicable means is available under
the provisions of this Act (other than this section) to
eliminate the risk, the Secretary may issue such order as may
be necessary to ensure that adequate safety notice is provided
in an appropriate form, by the persons and means best suited
under the circumstances, to all health care professionals who
prescribe, order, or use the in vitro clinical test and to any
other person (including developers, importers, distributors,
retailers, and users) who should properly receive such notice.
``(2) Notice to individuals.--An order under this
subsection shall require that the individuals subject to the
risk with respect to which the order is to be issued be
included in the persons to be notified of the risk unless the
Secretary determines that notice to such individuals would
present a greater danger to the health of such individuals than
no such notice. If the Secretary makes such a determination
with respect to such individuals, the order shall require the
health care professionals who prescribed, ordered, or used the
in vitro clinical test provide notification to the individuals
for whom the health professionals prescribed, ordered, or used
such test, of the risk presented by such in vitro clinical test
and of any action which may be taken by or on behalf of such
individuals to eliminate or reduce such risk. Before issuing an
order under this subsection, the Secretary shall consult with
the persons required to give notice under the order.
``(b) Repair, Replacement, or Refund.--
``(1) Determination after an informal hearing.--
``(A) In general.--If, after affording opportunity
for an informal hearing, the Secretary determines
that--
``(i) an in vitro clinical test presents an
unreasonable risk of substantial harm to the
public health;
``(ii) there are reasonable grounds to
believe that the in vitro clinical test was not
properly developed or manufactured considering
the state of the art as it existed at the time
of its development;
``(iii) there are reasonable grounds to
believe that the unreasonable risk was not
caused by failure of a person other than a
developer, importer, distributor, or retailer
of the in vitro clinical test to exercise due
care in the installation, maintenance, repair,
or use of the in vitro clinical test; and
``(iv) the notice authorized by subsection
(a) would not by itself be sufficient to
eliminate the unreasonable risk and action
described in paragraph (2) of this subsection
is necessary to eliminate such risk,
the Secretary may order the developer, importer, or any
distributor of such in vitro clinical test, or any
combination of such persons, to submit to him within a
reasonable time a plan for taking one or more of the
actions described in paragraph (2). An order issued
under the preceding sentence which is directed to more
than one person shall specify which person may decide
which action shall be taken under such plan and the
person specified shall be the person who the Secretary
determines bears the principal, ultimate financial
responsibility for action taken under the plan unless
the Secretary cannot determine who bears such
responsibility or the Secretary determines that the
protection of the public health requires that such
decision be made by a person (including a health
professional or user of the in vitro clinical test)
other than the person the Secretary determines bears
such responsibility.
``(B) Secretary approval of plan.--The Secretary
shall approve a plan submitted pursuant to an order
issued under subparagraph (A) unless the Secretary
determines (after affording opportunity for an informal
hearing) that the action or actions to be taken under
the plan or the manner in which such action or actions
are to be taken under the plan will not assure that the
unreasonable risk with respect to which such order was
issued will be eliminated. If the Secretary disapproves
a plan, the Secretary shall order a revised plan to be
submitted within a reasonable time. If the Secretary
determines (after affording opportunity for an informal
hearing) that the revised plan is unsatisfactory or if
no revised plan or no initial plan has been submitted
to the Secretary within the prescribed time, the
Secretary shall--
``(i) prescribe a plan to be carried out by
the person or persons to whom the order issued
under subparagraph (A) was directed; or
``(ii) after affording an opportunity for
an informal hearing, by order prescribe a plan
to be carried out by a person who is a
developer, importer, distributor, or retailer
of the in vitro clinical test with respect to
which the order was issued but to whom the
order under subparagraph (A) was not directed.
``(2) Actions on a plan.--The actions that may be taken
under a plan submitted under an order issued under paragraph
(1)(A) are as follows:
``(A) To repair the in vitro clinical test so that
it does not present the unreasonable risk of
substantial harm with respect to which the order under
paragraph (1)(A) was issued.
``(B) To replace the in vitro clinical test with a
like or equivalent test which is in conformity with all
applicable requirements of this Act.
``(C) To refund the purchase price of the in vitro
clinical test (less a reasonable allowance for use if
such in vitro clinical test has been in the possession
of the user for one year or more at the time of notice
ordered under subsection (a), or at the time the user
receives actual notice of the unreasonable risk with
respect to which the order was issued under paragraph
(1)(A), whichever occurs first).
``(3) No charge.--No charge shall be made to any person
(other than a developer, importer, distributor, or retailer)
for using a remedy described in paragraph (2) and provided
under an order issued under paragraph (1), and the person
subject to the order shall reimburse each person (other than a
developer, manufacturer, importer, distributor, or retailer)
who is entitled to such a remedy for any reasonable and
foreseeable expenses actually incurred by such person in using
such remedy.
``(c) Reimbursement.--An order issued under subsection (b)(1)(A)
with respect to an in vitro clinical test may require any person who is
a developer, importer, distributor, or retailer of the in vitro
clinical test to reimburse any other person who is a developer,
importer, distributor, or retailer of such in vitro clinical test for
such other person's expenses actually incurred in connection with
carrying out the order if the Secretary determines such reimbursement
is required for the protection of the public health. Any such
requirement shall not affect any rights or obligations under any
contract to which the person receiving reimbursement or the person
making such reimbursement is a party.
``(d) Recall Authority.--
``(1) In general.--If the Secretary finds that there is a
reasonable probability that an in vitro clinical test approved
under section 587B or offered under a technology certification
order under section 587D would cause serious, adverse health
consequences or death, including by the absence, significant
delay, or discontinuation of appropriate medical treatment, the
Secretary shall issue an order requiring the appropriate person
(including the developers, importers, distributors, or
retailers of the in vitro clinical test)--
``(A) to immediately cease distribution of such in
vitro clinical test; and
``(B) to immediately notify health professionals
and applicable in vitro clinical test user facilities
of the order and to instruct such professionals and
facilities to cease use of such in vitro clinical test.
``(2) Informal hearing.--The order issued under paragraph
(1)(A), shall provide the person subject to the order with an
opportunity for an informal hearing, to be held not later than
10 calendar days after the date of the issuance of the order,
on the actions required by the order and on whether the order
should be amended to require a recall of such in vitro clinical
test. If, after providing an opportunity for such a hearing,
the Secretary determines that inadequate grounds exist to
support the actions required by the order, the Secretary shall
vacate the order.
``(3) Amended order.--
``(A) In general.--If, after providing an
opportunity for an informal hearing under paragraph
(2), the Secretary determines that the order should be
amended to include a recall of the in vitro clinical
test with respect to which the order was issued, the
Secretary shall, except as provided in subparagraph
(B), amend the order to require a recall. The Secretary
shall specify a timetable in which the recall will
occur and shall require periodic reports describing the
progress of the recall.
``(B) Requirements.--An amended order under
subparagraph (A)--
``(i) shall not include recall of the in
vitro clinical test from individuals;
``(ii) shall not include recall of an in
vitro clinical test from test user facilities
if the Secretary determines that the risk of
recalling such in vitro clinical test from the
facilities presents a greater health risk than
the health risk of not recalling the in vitro
clinical test from use; and
``(iii) shall provide for notice to
individuals subject to the risks associated
with the use of such in vitro clinical test. In
providing the notice required by this clause,
the Secretary may use the assistance of health
professionals who prescribed, ordered, or used
such an in vitro clinical test for individuals.
``(4) Clarification.--The remedy provided by this
subsection shall be in addition to remedies provided by
subsections (a), (b), and (c).
``SEC. 587AA. APPLICABILITY.
``(a) In General.--An in vitro clinical test shall be subject to
the requirements of this subchapter, except as otherwise provided in
this subchapter. Laboratory operations shall not be subject to the
requirements of this subchapter.
``(b) Interstate Commerce.--Any in vitro clinical test that is
offered, including by making available for clinical use in the United
States is deemed to be an act that constitutes introduction into
interstate commerce for purposes of enforcing the requirements of this
Act.
``(c) Least Burdensome Requirements.--
``(1) In general.--In carrying out this subchapter, the
Secretary shall consider the least burdensome means necessary
to meet the applicable standard, and other regulatory
requirements, as determined by the Secretary.
``(2) Necessary defined.--For purposes of paragraph (1),
the term `necessary' means the minimum required information
that would support a determination by the Secretary that the
application meet the applicable standard or regulatory
requirement, as determined by the Secretary.
``(d) Service of Orders.--Orders of the Secretary under this
section with respect to applications under subsection (a) or (b) of
section 587B or supplements under subsection (f) of such section shall
be served--
``(1) in person by any officer or employee of the
Department of Health and Human Services designated by the
Secretary; or
``(2) by mailing the order by registered mail or certified
mail or electronic equivalent addressed to the applicant at the
last known address in the records of the Secretary.
``(e) Laboratories and Blood and Tissue Establishments.--
``(1) Relation to laboratory certification pursuant to
section 353 of the public health service act.--Nothing in this
subchapter shall be construed to modify the authority of the
Secretary with respect to laboratories or clinical laboratories
under section 353 of the Public Health Service Act.
``(2) Avoiding duplication.--In implementing this
subchapter, the Secretary shall avoid issuing or enforcing
regulations or guidance that are duplicative of regulations or
guidance under section 353 of the Public Health Service Act
such that laboratories would be subject to conflicting
regulatory obligations with respect to the same activity.
``(3) Blood and tissue.--Nothing in this subchapter shall
be construed to modify the authority of the Secretary with
respect to laboratories, establishments, or other facilities to
the extent they are engaged in the propagation, manufacture, or
preparation, including filling, labeling, packaging, and
storage, of blood, blood components, human cells, tissues, or
tissue products pursuant to any requirements under this Act or
section 351 or 361 of the Public Health Service Act.
``(f) Not Combination Product.--
``(1) In general.--A product constituted of a device and an
in vitro clinical test is not a combination product and may be
regulated as a device or as a device and in vitro clinical
test, notwithstanding section 201(ss)(3).
``(2) Guidance.--Not later than October 1, 2026, the
Secretary shall issue final guidance, after an opportunity for
public comment, addressing the considerations for regulating a
product described in paragraph (1). Such guidance shall take
into account the least burdensome requirements under subsection
(c).
``(g) Practice of Medicine.--Nothing in this subchapter shall be
construed to limit or interfere with the authority of a health care
practitioner to prescribe or administer any lawfully offered in vitro
clinical test for any condition or disease within a legitimate health
care practitioner-patient relationship pursuant to applicable Federal
or State law.
``(h) Sale, Distribution, Labeling.--Nothing in this section shall
be construed to limit the authority of the Secretary to establish or
enforce restrictions on the sale, distribution, or labeling of an in
vitro clinical test under this Act.
``(i) Promotion of Unapproved Uses.--Nothing in this section shall
be construed to alter any prohibition on the promotion of unapproved
uses of legally offered in vitro clinical tests.
``(j) Voluntary Submissions.--Nothing in section 587C shall be
construed to prevent a developer developing a test described in such
section, including an academic medical center laboratory described in
subsection (a)(7) of such section, from filing an application under
section 587B or section 587D, or from adhering to the requirements of
section 587K with regard to a test protocol described in section 587K
or for any other test or use of a test.
``SEC. 587BB. JUDICIAL REVIEW.
``(a) In General.--Not later than 30 days after an order issued
pursuant to section 587B or 587D, any person adversely affected by such
order may file a petition with the United States Court of Appeals for
the District of Columbia or for the circuit wherein such person resides
or has a principal place of business for judicial review of such order,
in accordance with the procedure set forth in section 517(a).
``(b) Application of Provisions.--Subsections (a) through (e) of
section 517 shall apply with respect to a petition under subsection (a)
of this section in the same manner such subsections apply to a petition
under section 517. Subsection (f) of section 517 shall apply to an
order issued under section 587B or 587D.''.
SEC. 4. ENFORCEMENT AND OTHER PROVISIONS.
(a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended--
(1) in paragraphs (a), (b), (c), (g), (h), (k), (q), (r),
and (y), by inserting ``in vitro clinical test,'' after
``device,'' each place it appears;
(2) in paragraph (g), by inserting after ``misbranded'' the
following: ``, and the development within any Territory of any
in vitro clinical test that is adulterated or misbranded'';
(3) in paragraph (y), by inserting ``or 587Q'' after
``section 523'' each place it appears;
(4) in paragraph (ff), by striking ``or device'' and
inserting ``, device, or in vitro clinical test''; and
(5) by adding at the end, the following:
``(fff)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp, tag,
label, or other identification upon any in vitro clinical test or
container, packaging, or labeling thereof so as to render such in vitro
clinical test a counterfeit in vitro clinical test.
``(2) Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing any punch, die, plate, stone, or
other thing designed to print, imprint, or reproduce the trademark,
trade name, or other identifying mark or imprint of another or any
likeness of any of the foregoing upon any in vitro clinical test or
container, packaging, or labeling thereof so as to render such in vitro
clinical test a counterfeit in vitro clinical test.
``(3) The doing of any act which causes an in vitro clinical test
to be a counterfeit in vitro clinical test, or the sale or dispensing,
or the holding for sale or dispensing, of a counterfeit in vitro
clinical test.
``(ggg)(1) The introduction or delivery for introduction into
interstate commerce of an in vitro clinical test in violation of
section 587A(a).
``(2) The making of a false, fraudulent, or deceptive statement
about an in vitro clinical test that is exempt from premarket review
under section 587C.
``(3) The failure to maintain complete and accurate documentation
for an exemption as required under section 587C or the failure to
provide labeling required under section 587L.
``(4) With respect to an in vitro clinical test, the submission of
any application, report, or listing under this Act that is false or
misleading in any material respect.
``(5) The failure to comply with a condition of approval, or
restriction required under an approved application under section 587B;
the failure to perform a risk analysis required by section 587B; the
failure to submit an annual update required under section
587J(c)(2)(B); or the failure to complete postmarket surveillance as
required under section 587X.
``(6) The failure to comply with applicable requirements to submit
an application or report under section 587D(e).
``(7) The failure to comply with applicable mitigating measures
established under section 587E or to submit, maintain, or make
available the documentation required under section 587E(b); or the
failure to comply with applicable performance standards established
under section 587R.
``(8) The failure to register in accordance with section 587J, the
failure to provide information required under section 587J(b), or the
failure to maintain or submit information required under section
587J(c).
``(9) The failure to comply with requirements under section 587M or
587N, the failure to comply with a restriction required under section
587O, or the failure to comply with labeling and advertising
requirements under section 587O(b).
``(10) The failure to comply with the requirements of section 587Q.
``(11) The failure to comply with any requirement of section 587S;
the failure to furnish any notification, information, material, or
report required under section 587S; or the failure to comply with an
order issued under section 587S.
``(12) The failure to furnish information requested by the
Secretary under 587G(d)(2).''.
(b) Penalties.--Section 303 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 333) is amended--
(1) in subsection (b)(8), by inserting ``or counterfeit in
vitro clinical test'' after ``counterfeit drug'';
(2) in subsection (c)--
(A) by striking ``; or (5)'' and inserting ``;
(5)''; and
(B) by inserting before the period at the end the
following: ``; or (6) for having violated section
301(fff)(2) if such person acted in good faith and had
no reason to believe that use of the punch, die, plate,
stone, or other thing involved would result in an in
vitro clinical test being a counterfeit in vitro
clinical test, or for having violated section
301(fff)(3) if the person doing the act or causing it
to be done acted in good faith and had no reason to
believe that the in vitro clinical test was a
counterfeit in vitro clinical test''; and
(3) in subsection (f)(1)--
(A) in subparagraph (A)--
(i) by inserting ``or in vitro clinical
tests'' after ``which relates to devices'';
(ii) by inserting ``or section 587Q(a)(1)''
after ``section 704(g)''; and
(iii) by inserting ``or in vitro clinical
tests, as applicable'' before the period at the
end of the second sentence; and
(B) in subparagraph (B)(i), by striking ``or
520(f)'' and inserting ``, 520(f), 587K, or 587M,''.
(c) Seizure.--Section 304 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 334) is amended--
(1) in subsection (a)(2)--
(A) by striking ``, and (E)'' and inserting ``,
(E)''; and
(B) by inserting before the period at the end the
following: ``, and (F) Any in vitro clinical test that
is a counterfeit in vitro clinical test, (G) Any
container, packaging, or labeling of a counterfeit in
vitro clinical test, and (H) Any punch, die, plate,
stone, labeling, container, or other thing used or
designed for use in making a counterfeit in vitro
clinical test'';
(2) in subsection (d)(1), by inserting ``in vitro clinical
test,'' after ``device,''; and
(3) in subsection (g)--
(A) in paragraph (1), by inserting ``, in vitro
clinical test,'' after ``device'' each place it
appears; and
(B) in paragraph (2)--
(i) in subparagraph (A), by inserting ``,
in vitro clinical test,'' after ``device''; and
(ii) in subparagraph (B), by inserting ``or
in vitro clinical test'' after ``device'' each
place it appears.
(d) Debarment, Temporary Denial of Approval, and Suspension.--
Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
335a) is amended by adding at the end the following:
``(n) In Vitro Clinical Tests; Mandatory Debarment Regarding Third-
Party Inspections and Reviews.--
``(1) In general.--If the Secretary finds that a person has
been convicted of a felony for a violation of section 301(gg)
or 301(fff)(1), the Secretary shall debar such person from
being accredited under section 587Q and from carrying out
activities under an agreement described in section 803(b).
``(2) Debarment period.--The Secretary shall debar a person
under paragraph (1) for the following periods:
``(A) The period of debarment of a person (other
than an individual) shall not be less than 1 year or
more than 10 years, but if an act leading to a
subsequent debarment under such paragraph occurs within
10 years after such person has been debarred under such
paragraph, the period of debarment shall be permanent.
``(B) The debarment of an individual shall be
permanent.
``(3) Termination of debarment; judicial review; other
matters.--Subsections (c)(3), (d), (e), (i), (j), and (l)(1)
apply with respect to a person (other than an individual) or an
individual who is debarred under paragraph (1) to the same
extent and in the same manner as such subsections apply with
respect to a person who is debarred under subsection (a)(1), or
an individual who is debarred under subsection (a)(2),
respectively.''.
(e) Expanded Access to Unapproved Therapies and Diagnostics.--
Section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb) is amended--
(1) in subsections (a) through (d)--
(A) by striking ``or investigational devices'' each
place it appears and inserting ``, investigational
devices, or investigational in vitro clinical tests'';
and
(B) by striking ``or investigational device'' each
place it appears (other than the second such place in
paragraph (3)(A)) of subsection (c)) and inserting ``,
investigational device, or investigational in vitro
clinical test'';
(2) in subsection (b)(4) by striking ``or 520(g)'' each
place it appears and inserting ``, 520(g), or 587S'';
(3) in subsection (c)--
(A) by amending the subsection heading to read:
``Treatment Investigational New Drug Applications,
Treatment Investigational Device Exemptions, and
Treatment Investigational in Vitro Clinical Test
Exemptions.'';
(B) in paragraph (3)(A), by striking ``or
investigational device exemption in effect under
section 520(g)'' and inserting ``, investigational
device exemption in effect under section 520(g), or
investigational in vitro clinical test exemption under
section 587S'';
(C) by striking ``or treatment investigational
device exemption'' each place it appears and inserting
``, treatment investigational device exemption, or
treatment investigational in vitro clinical test
exemption'';
(D) in paragraph (5), by striking ``or 520(g)'' and
inserting ``, 520(g), or 587S''; and
(E) in the matter following paragraph (7) by
striking ``or 520(g)'' each place it appears and
inserting ``, 520(g), or 587S''; and
(4) by amending subsection (e) to read as follows:
``(e) Definitions.--In this section, the terms `investigational
drug', `investigational device', `investigational in vitro clinical
test', `treatment investigational new drug application', `treatment
investigational device exemption', and `treatment investigational in
vitro clinical test exemption' shall have the meanings given the terms
in regulations prescribed by the Secretary.''.
(f) Optimizing Global Clinical Trials.--Section 569A(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8a(b)) is
amended--
(1) by striking ``subsection'' each place it appears and
inserting ``paragraph''; and
(2) by inserting ``an in vitro clinical test, as defined in
paragraph (ss) of such section,'' before ``or a biological
product''.
(g) Patient Participation in Medical Product Discussion.--The
heading of subsection (a) of section 569C of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-8c) is amended by striking ``Drugs
and Devices'' and inserting ``Drugs, Devices, and in Vitro Clinical
Tests''.
(h) Regulations and Hearings.--Clause (ii) of section 701(h)(1)(C)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)) is
amended--
(1) by inserting ``and in vitro clinical tests'' after
``devices''; and
(2) by moving the margin of such clause 2 ems to the left.
(i) Records.--Section 703 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 373) is amended--
(1) by inserting ``in vitro clinical tests,'' after
``devices,'' each place such term appears; and
(2) by inserting ``in vitro clinical test,'' after
``device,'' each place such term appears.
(j) Factory Inspection.--Section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374) (other than subsection (g)) is amended--
(1) by striking ``drugs or devices'' each place it appears
and inserting ``drugs, devices, or in vitro clinical tests'';
(2) in subsection (a)(1), in the fourth sentence, by
striking ``or chapter IX'' and inserting ``section 587S,
section 587M, section 587N, or chapter IX'';
(3) after making the amendments in paragraphs (1) and (2),
by inserting ``in vitro clinical tests,'' after ``devices,''
each place it appears;
(4) in subsection (a)(2)(B)--
(A) by inserting ``or in vitro clinical tests''
after ``prescribe or use devices''; and
(B) by inserting ``or in vitro clinical tests''
after ``process devices'';
(5) by inserting ``in vitro clinical test,'' after
``device,'' each place it appears;
(6) in subsection (e), by inserting ``, or section 587M,
587N, or 587S,'' after ``section 519 or 520(g)'';
(7) in subsection (f)(3)--
(A) in subparagraph (A), by striking ``or'' at the
end;
(B) in subparagraph (B), by striking the period at
the end and inserting ``; or''; and
(C) after subparagraph (B), by inserting the
following:
``(C) is accredited under section 587Q.''; and
(8) by adding at the end the following:
``(i) For purposes of this section, the term `establishment'
includes a laboratory performing an in vitro clinical test.''.
(k) Publicity.--Section 705(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 375(b)) is amended by inserting ``in vitro
clinical tests,'' after ``devices,''.
(l) Presumption.--Section 709 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379a) is amended by inserting ``in vitro
clinical test,'' after ``device,''.
(m) Listing and Certification of Color Additives for Foods, Drugs,
and Cosmetics.--Section 721(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379e(a)) is amended--
(1) in the matter preceding paragraph (1), by inserting
``or in vitro clinical tests'' after ``or devices''; and
(2) in the flush text following paragraph (2)--
(A) by inserting ``or an in vitro clinical test''
after ``a device''; and
(B) by inserting ``or in vitro clinical tests''
after ``devices''.
(n) Imports and Exports.--Section 801 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381) is amended--
(1) in subsection (a)--
(A) by inserting ``in vitro clinical tests,'' after
``devices,'' each place it appears; and
(B) by inserting ``in the case of an in vitro
clinical test, the test does not conform to the
applicable requirements of section 587K, or'' after
``requirements of section 520(f), or'';
(2) in subsection (d)(3)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
inserting ``and no component of an in vitro
clinical test or other article of in vitro
clinical test that requires further
processing,'' after ``health-related
purposes'';
(ii) in clause (i), by striking ``drug or
device'' and inserting ``drug, device, or in
vitro clinical test''; and
(iii) in clause (i)(I), by inserting ``in
vitro clinical test,'' after ``device,''; and
(B) in subparagraph (B), by inserting ``in vitro
clinical test,'' after ``device,'';
(3) in subsection (e)(1), by inserting ``in vitro clinical
test,'' after ``device,''; and
(4) in subsection (o)--
(A) by inserting ``or in vitro clinical test''
after ``device''; and
(B) by inserting ``, or under section 587J of each
foreign establishment,'' after ``section 510(i) of each
establishment''.
(o) Office of International Relations.--Section 803 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 383) is amended--
(1) in subsection (b)--
(A) in the matter preceding paragraph (1), by
inserting ``and in vitro clinical tests'' after
``devices''; and
(B) in paragraph (1), by striking ``, and'' and
inserting ``and quality requirements established under
section 587K; and''; and
(2) in subsection (c)--
(A) in paragraph (2), by inserting ``in vitro
clinical tests,'' after ``devices,''; and
(B) in paragraph (4), by inserting ``or in vitro
clinical tests'' after ``devices''.
(p) Recognition of Foreign Government Inspections.--Section
809(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
384e(a)(1)) is amended by inserting ``, or of foreign establishments
registered under section 587J,'' after ``510(h)''.
(q) Food and Drug Administration.--Section 1003(b)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)) is amended--
(1) in subparagraph (D), by striking ``and'' at the end;
(2) in subparagraph (E), by striking the semicolon at the
end and inserting ``; and''; and
(3) by adding at the end the following:
``(F) in vitro clinical tests are analytically and
clinically valid;''.
(r) Office of Women's Health.--Section 1011(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 399b(b)) is amended--
(1) in paragraph (1), by inserting ``in vitro clinical
tests,'' after ``devices,''; and
(2) in paragraph (4), by inserting ``in vitro clinical test
developers,'' after ``device manufacturers,''.
(s) Countermeasure Provisions of the Public Health Service Act.--
Title III of the Public Health Service Act is amended--
(1) in section 319F-1(a)(2)(A) (42 U.S.C. 247d-
6a(a)(2)(A))--
(A) in the matter preceding clause (i)--
(i) by striking ``or device'' and inserting
``device''; and
(ii) by inserting ``or an in vitro clinical
tests (as that term is defined in section
201(ss) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(ss))),'' after ``Act (21
U.S.C. 321(h))),''; and
(B) in each of clauses (ii) and (iii), by striking
``or device'' and inserting ``device, or in vitro
clinical test'';
(2) in section 319F-2(c)(1)(B) (42 U.S.C. 247d-
6b(c)(1)(B))--
(A) by striking ``or device'' and inserting
``device''; and
(B) by inserting ``, or an in vitro clinical test
(as that term is defined in section 201(ss) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(ss)))'' after ``Act (21 U.S.C. 321(h))),''; and
(3) in section 319F-3(i)(7) (42 U.S.C. 247d-6d(i)(7))--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``or device'' and inserting
``device''; and
(ii) by inserting ``or an in vitro clinical
tests (as that term is defined in section
201(ss) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(ss))),'' after ``Act (21
U.S.C. 321(h))'';
(B) in subparagraph (A)--
(i) by moving the margin of clause (iii) 2
ems to the left; and
(ii) in clause (iii), by striking ``or
device'' and inserting ``device, or in vitro
clinical test''; and
(C) in subparagraph (B)--
(i) in clause (i), by striking ``approved
or cleared'' and inserting ``approved, cleared,
or offered under a technology certification
order''; and
(ii) in clause (ii), by striking ``or
520(g)'' and inserting ``, 520(g), or 587S''.
SEC. 5. TRANSITION.
(a) Implementation.--
(1) Effective date.--
(A) In general.--Except as otherwise provided in
this section, the amendments made by this Act shall
take effect on October 1, 2028 (in this section and in
subchapter J of chapter V of the Federal Food, Drug,
and Cosmetic Act, as added by this Act, referred to in
this section as the ``effective date of this Act'').
(B) Exceptions.--
(i) In general.--The Secretary of Health
and Human Services (in this section referred to
as the ``Secretary'') may take the actions
described in paragraph (2), and may expend such
funds as the Secretary determines necessary to
ensure an orderly transition prior to the
effective date of this Act.
(ii) Implementation of certain
provisions.--The Secretary may implement
sections 587J and 587U of the Federal Food,
Drug, and Cosmetic Act (as added by section 3)
beginning on October 1, 2024, and such sections
may take effect not earlier than October 1,
2028, to the extent and for the purposes
indicated in such sections. In the case of a
developer who, between October 1, 2024, and the
effective date of this Act, registers under
such section 587J with respect to an article
that is an in vitro clinical test, such
developer shall not be required to register
with respect to such article under section 510
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360).
(2) Actions.--The Secretary--
(A) shall--
(i) within 1 year of the date of enactment
of this Act, hold the public meetings described
in section 587D(i) of the Federal Food, Drug,
and Cosmetic Act (as added by section 3); and
(ii) within 3 years of the date of
enactment of this Act, promulgate final
regulations required under the amendments made
by this Act; and
(B) may take additional actions after the date of
enactment that the Secretary determines necessary to
ensure an orderly transition, including--
(i) establishment of mitigating measures
for an in vitro clinical test or category of in
vitro clinical tests, which may not take effect
until after the effective date described in
paragraph (1)(A); and
(ii) establishment of the comprehensive
test information system under section 587T of
the Federal Food, Drug, and Cosmetic Act, as
added by section 3.
(3) Applicability of guidance and regulations.--
Notwithstanding the date on which guidance or regulations are
issued under paragraph (2) and section 587K of the Federal
Food, Drug, and Cosmetic Act, as added by section 3, no
guidance or regulations issued pursuant to the amendments made
by this Act shall be implemented or take effect until the
effective date of this Act, except as otherwise specified in
this Act (including the amendments made by this Act).
(4) Implementation requirements.--In the event that the
Secretary fails to promulgate the regulations required under
section 587B(a)(4), 587D(j), or 587S(b)(1) of the Federal Food,
Drug, and Cosmetic Act, as added by section 3, by the deadline
described in subsection (a)(2)(A)(ii), the Secretary shall,
within 15 days of such missed deadline--
(A) submit a report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives providing information related to the
status of such regulations, including--
(i) a rationale for missing the applicable
deadline described in such subsection;
(ii) a description of actions taken to the
date of submission of the report to promulgate
each such regulations;
(iii) the expected timeline for
promulgating each such regulations;
(iv) an assessment of the impact of the
delay in promulgating such regulations on
developers of in vitro clinical tests,
including an economic assessment; and
(v) an assessment of the impact of the
delay in promulgating such regulations on
patients; and
(B) open a public docket for purposes of soliciting
public comments on the impact of the delay in
promulgating such regulations.
(b) Application of Authorities to in Vitro Clinical Tests Under
Review on the Effective Date of This Act.--For any in vitro clinical
test for which a submission for approval under section 515 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e), clearance under
section 510(k) of such Act (21 U.S.C. 360(k)), authorization under
section 513(f)(2) of such Act (21 U.S.C. 360c(f)(2)), or licensure
under section 351 of the Public Health Service Act (42 U.S.C. 262) is
pending on the effective date of this Act, including transitional in
vitro clinical tests as described in subsection (c), the Secretary may
review and take action on such submission after the effective date of
this Act according to the statutory provision under which such
submission was submitted.
(c) Application of Authorities to Transitional In Vitro Clinical
Tests.--
(1) Definition.--For purposes of this section, the term
``transitional in vitro clinical test'' means an in vitro
clinical test that--
(A)(i) is first offered for clinical use during the
period beginning on the date that is 45 days after the
date of enactment of this Act and ending on the
effective date of this Act; or
(ii) is offered solely for investigational use
during the period beginning on the date of enactment of
this Act and ending on the effective date of this Act;
(B) is developed by a clinical laboratory certified
by the Secretary under section 353 of the Public Health
Service Act (42 U.S.C. 263a) that meets the
requirements for performing high-complexity testing and
performed--
(i) in the same clinical laboratory in
which the test was developed and for which a
certification is still in effect under such
section 353 that meets the requirements to
perform tests of high complexity;
(ii) by another laboratory for which a
certificate is in effect under such section 353
that meets the requirements to perform tests of
high complexity, is within the same corporate
organization, and has common ownership by the
same parent corporation as the laboratory in
which the test was developed; or
(iii) in the case of a test that was
developed by the Centers for Disease Control
and Prevention or another laboratory in a
public health laboratory network coordinated or
managed by the Centers for Disease Control and
Prevention, by a clinical laboratory for which
a certificate is in effect under such section
353 that meets the requirements to perform
tests of high complexity, and that is within a
public health laboratory network coordinated or
managed by the Centers for Disease Control and
Prevention; and
(C) when first offered, is not approved under
section 515 of the Federal Food, Drug, and Cosmetic
Act, cleared under section 510(k) of such Act,
authorized under section 513(f)(2) of such Act, subject
to a humanitarian device exemption under section 520(m)
of such Act (21 U.S.C. 360j(m)), subject to an
exemption for investigation use under section 520(g) of
such Act (21 U.S.C. 360j(g)), authorized under section
564 of such Act (21 U.S.C. 360bbb-3), or licensed under
section 351 of the Public Health Service Act (42 U.S.C.
262).
(2) Premarket review or technology certification.--A
transitional in vitro clinical test that is not exempt from
premarket review under section 587C of the Federal Food, Drug,
and Cosmetic Act, as added by section 3, may continue to be
offered, sold, or distributed, as applicable, without marketing
authorization until completion of the Secretary's review of the
premarket application or technology certification application
under section 587B or 587D, as applicable, if--
(A) such in vitro clinical test is a high-risk test
(as defined in section 587 of the Federal Food, Drug,
and Cosmetic Act, as added by section 3) and the
application for such test is submitted not later than
90 days after the effective date of this Act; or
(B) such in vitro clinical test is a moderate-risk
test (as defined in such section 587), the developer
lists the test in accordance with section 587J within
10 calendar days of the effective date of this
subchapter, and the application for such test is
submitted not later than 1 year after the effective
date of this Act.
(3) Investigational use request.--A transitional in vitro
clinical test described in paragraph (1)(A)(ii) that is used in
a significant risk investigation may continue to be offered for
investigational use until completion of the Secretary's review
of an application under 587S, if such application is submitted
not later than 90 days after the effective date of this Act.
(4) Tests approved by new york state.--Notwithstanding
paragraph (2), a transitional in vitro clinical test that has
been approved by the New York State Department of Health may
continue to be offered, sold, or distributed, as applicable,
after the effective date if--
(A) starting on the effective date of this Act, the
in vitro clinical test complies with the requirements
of subchapter J of the Federal Food, Drug, and Cosmetic
Act, as added by this Act, except for section 587B of
the Federal Food, Drug, and Cosmetic Act, as added by
section 3, and design control provisions of section
587K of such Act;
(B) each test report for the test bears a statement
of adequate prominence that reads as follows: ``This in
vitro clinical test was developed and first introduced
prior to the effective date of the VALID Act of 2023.
This test was approved by the New York State Department
of Health, but the test has not been reviewed by the
Food and Drug Administration.'';
(C) a premarket application under section 587B of
the Federal Food, Drug, and Cosmetic Act, as added by
section 3, or technology certification application
under section 587D of such Act, as added by section 3,
is submitted no later than--
(i) 5 years after the effective date of
this Act, if the in vitro clinical test is
approved by the New York State Department of
Health as a genetic testing molecular test, a
microbiology molecular test, an oncology
molecular test, or any other type of molecular
test; or
(ii) 2 years after the effective date of
this Act, if the in vitro clinical test is
approved by the New York State Department of
Health as a type of test not described in
clause (i); and
(D) a test in compliance with this paragraph may
continue to be offered, sold, or distributed, as
applicable, until the completion of the Secretary's
review of the premarket application or technology
certification application described in subparagraph
(C).
(d) Conversion.--
(1) Deemed premarket approval.--Beginning on the effective
date of this Act--
(A) any in vitro clinical test with a premarket
approval under section 515 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e) or a licensure under
section 351 of the Public Health Service Act (42 U.S.C.
262) is deemed to be approved pursuant to an
application under section 587B(a) of the Federal Food,
Drug, and Cosmetic Act, as added by this Act; and
(B) any in vitro clinical test (as so defined) that
was cleared under section 510(k) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(k)) or authorized
under section 513(f)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(f)(2)) is deemed to be
approved pursuant to an application under section
587B(b) of the Federal Food, Drug, and Cosmetic Act, as
added by this Act.
(2) Deemed investigational use exemption.--Any in vitro
clinical test that has an investigational device exemption in
effect under section 520(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j(g)) is deemed to have an
investigational use exemption in effect under section 587S of
such Act, as added by this Act, beginning on the effective date
of this Act.
(3) Deemed humanitarian device exemption.--Any in vitro
clinical test that has an approved humanitarian device
exemption under section 520(m) of such Act is deemed to have a
humanitarian test exemption under section 587A(g) of such Act,
as added by this Act, beginning on the effective date of this
Act.
(4) Deemed designated breakthrough.--Any in vitro clinical
test that has received a breakthrough device designation under
section 515B(e)(1)(D) of such Act (21 U.S.C. 360e-3(e)(1)(D))
is deemed to have a breakthrough in vitro clinical test
designation under section 587C of such Act, as added by this
Act, beginning on the effective date of this Act.
(5) Deemed request for informal feedback.--With regard to
any in vitro clinical test that is the subject of a pre-
submission request described in the guidance, ``Requests for
Feedback and Meetings for Medical Device Submissions: The Q-
Submission Program'', issued by the Food and Drug
Administration on January 6, 2021, such request is deemed to
constitute a request for informal feedback under section 587F
of the Federal Food, Drug, and Cosmetic Act, as added by
section 3, beginning on the effective date of this Act.
(e) Previously Classified Devices.--Notwithstanding section 587 of
the Federal Food, Drug, and Cosmetic Act, as added by section 3, for
purposes of subchapter J of chapter V of such Act, as added by section
3, the following apply:
(1) In the case of an in vitro clinical test type that has
been classified by the Secretary as a class I device pursuant
to section 513 of such Act (21 U.S.C. 360c), such in vitro
clinical test shall be low-risk, unless the in vitro clinical
test is a test described in the second sentence of section
510(l)(1) of such Act or the test is redesignated by the
Secretary pursuant to section 587F of such Act.
(2) In the case of an in vitro clinical test type that has
been classified by the Secretary as a class II device pursuant
to section 513 of such Act (21 U.S.C. 360c), such in vitro
clinical test shall be moderate-risk, unless inaccurate results
from the test would be immediately life threatening or the test
is redesignated by the Secretary pursuant to section 587F of
such Act.
(3) In the case of an in vitro clinical test type that has
been classified by the Secretary as a class III device pursuant
to section 513 of such Act (21 U.S.C. 360c) or an in vitro
clinical test licensed pursuant to section 351 of the Public
Health Service Act (42 U.S.C. 262), such in vitro clinical test
shall be high-risk, unless redesignated by the Secretary
pursuant to section 587F of the Federal Food, Drug, and
Cosmetic Act.
SEC. 6. EMERGENCY USE AUTHORIZATION.
(a) In General.--Section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
(1) by inserting ``or developer'' after ``manufacturer'',
each place such term appears;
(2) in subsection (a)--
(A) in paragraphs (1) and (4)(C), by inserting ``in
vitro clinical test,'' before ``or biological product''
each place such term appears;
(B) in paragraph (2)(A), by striking ``or 515'' and
inserting ``515, or 587B''; and
(C) by adding at the end the following:
``(F) The terms `develop' and `developer', with
respect to an in vitro clinical test, have the meanings
given such terms in section 587.'';
(3) in subsection (b), by inserting ``or developer'' after
``manufacturer'' each place such term appears;
(4) in subsection (e)--
(A) by inserting ``or developers'' after
``manufacturers'' each place such term appears;
(B) in paragraph (2)(B)(ii), by inserting ``or
develop'' after ``not manufacture'';
(C) in paragraph (3)--
(i) in subparagraph (A), by striking ``or
520(f)(1)'' and inserting ``, 520(f)(1), or
587V'';
(ii) in subparagraph (B), by striking
``and'' at the end;
(iii) in subparagraph (C), by striking the
period and inserting `` or 587O; and''; and
(iv) by adding at the end the following:
``(D) quality requirements (with respect to in
vitro clinical tests) under section 587K.''; and
(D) in paragraph (4)--
(i) in subparagraph (A), by striking ``;
or'' and inserting a semicolon;
(ii) in subparagraph (B), by striking the
period and inserting ``; or''; and
(iii) by adding at the end the following:
``(C) with respect to in vitro clinical tests,
requirements applicable to restricted in vitro clinical
tests pursuant to section 587O.'';
(5) in subsection (k), by striking ``or 520(g)'' and
inserting ``520(g), or 587S''; and
(6) in subsection (m)--
(A) in the subsection heading, by striking
``Laboratory Tests Associated With Devices'' inserting
``in Vitro Clinical Tests'' after ``Devices''; and
(B) in paragraph (1)--
(i) by striking ``to a device'' and
inserting ``to an in vitro clinical test''; and
(ii) by striking ``such device'' and
inserting ``such in vitro clinical test''.
(b) Emergency Use of Medical Products.--Section 564A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a) is amended--
(1) in subsection (a)--
(A) in paragraph (2), by inserting ``in vitro
clinical test,'' after ``device,''; and
(B) by adding at the end the following:
``(3) Developer.--The term `developer', with respect to an
in vitro clinical test, has the meaning given such term in
section 587.'';
(2) by inserting ``or developer'' after ``manufacturer''
each place it appears; and
(3) in subsection (c)(1)--
(A) by inserting ``or quality requirements'' after
``good manufacturing practice requirements''; and
(B) by striking ``or 520(f)(1)'' and inserting ``,
520(f)(1), or 587K''.
(c) Products Held for Emergency Use.--Section 564B(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b(2)) is
amended--
(1) in subparagraph (A), by striking ``or 515'' and
inserting ``515, or 587B''; and
(2) in subparagraph (B), by striking ``or 520'' and
inserting 520, or 587S.
SEC. 7. ANTIMICROBIAL SUSCEPTIBILITY TESTS.
Section 511A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360a-2) is amended--
(1) in subsection (a)(1)(C)--
(A) by striking ``clear under section 510(k),
classify under section 513(f)(2), or approve under
section 515'' and inserting ``approve under section
587B, exempt from premarket review under section 587C,
or grant a technology certification order under section
587D''; and
(B) by striking ``testing devices'' and inserting
``in vitro clinical tests'';
(2) in subsection (c)(5)--
(A) by striking ``drug or device'' and inserting
``drug, device, or in vitro clinical test''; and
(B) by striking ``the drug or the device'' and
inserting ``the drug, device, or in vitro clinical
test'';
(3) in subsection (e)--
(A) in the heading, by striking ``Testing Devices''
and inserting ``In Vitro Clinical Tests'';
(B) in paragraph (1)--
(i) by striking ``510, 513, and 515,'' and
inserting ``587B, and 587D'';
(ii) by striking ``antimicrobial
susceptibility testing device'' and inserting
``antimicrobial susceptibility in vitro
clinical test''; and
(iii) by striking ``such device'' and
inserting ``such in vitro clinical test''; and
(C) in paragraph (2)--
(i) in the heading, by striking ``testing
devices'' and inserting ``in vitro clinical
tests'';
(ii) in subparagraphs (A) and (B) (other
than clause (iii) of such subparagraph (B)), by
striking ``device'' each place it appears and
inserting ``in vitro clinical test'';
(iii) in subparagraph (B)(iii), by striking
``a device'' and inserting ``an in vitro
clinical test''; and
(iv) by amending subparagraph (C) to read
as follows:
``(C) The antimicrobial susceptibility in vitro
clinical test meets all other requirements to be
approved under section 587B, to be exempted from
premarket review under section 587C, or to be offered
under a technology certification order under section
587D.'';
(4) in subsection (f), by amending paragraph (1) to read as
follows:
``(1) The term `antimicrobial susceptibility in vitro
clinical test' means an in vitro clinical test that utilizes
susceptibility test interpretive criteria to determine and
report the in vitro susceptibility of certain microorganisms to
a drug (or drugs).''; and
(5) in subsection (g)(2)--
(A) by amending the matter preceding subparagraph
(A) to read as follows:
``(2) with respect to approving an application under
section 587B or granting a technology certification order under
section 587D--''; and
(B) in subparagraph (A)--
(i) by striking ``device'' and inserting
``in vitro clinical test''; and
(ii) by striking ``antimicrobial
susceptibility testing device'' and inserting
``antimicrobial susceptibility in vitro
clinical test''.
SEC. 8. COMBINATION PRODUCTS.
(a) In General.--Section 503(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353(g)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), by striking ``or
biological product'' and inserting ``in vitro clinical
test (except for a product constituted of a device and
an in vitro clinical test), or biological product'';
(B) in subparagraph (B), by adding at the end the
following: ``For purposes of this Act, a product that
constitutes a combination of a device and an in vitro
clinical test is not a combination product within the
meaning of this subsection and an in vitro clinical
test that is offered as a separate product intended to
inform the use of a drug, biological product, or device
is not a combination product within the meaning of this
subsection.''; and
(C) in subparagraph (D)(ii)--
(i) by inserting ``or in vitro clinical
test'' after ``device''; and
(ii) by inserting ``and in vitro clinical
tests'' before ``shall'';
(2) in paragraph (3), by striking ``safety and
effectiveness or substantial equivalence'' and inserting
``safety and effectiveness, substantial equivalence, or
analytical validity and clinical validity'' before ``for the
approved constituent part'';
(3) in paragraph (4)--
(A) in subparagraph (A), by striking ``or 513(f)(2)
(submitted in accordance with paragraph (5))'' and
inserting ``513(f)(2) (submitted in accordance with
paragraph (5)), 587B, or 587D''; and
(B) in subparagraph (C), by striking ``or 515'' and
inserting ``515, or 587B, or that is under an order
under section 587D'';
(4) in paragraph (5)(A), by striking ``or 510(k)'' and
inserting ``, 510(k), 587B, or 587D'';
(5) in paragraph (7), by striking ``or substantial
equivalence'' and inserting ``, substantial equivalence, or
analytical validity and clinical validity'';
(6) in paragraph (8), by adding at the end the following:
``(I) This paragraph shall not apply to a product
constituted of a device and an in vitro clinical
test.''; and
(7) in paragraph (9)--
(A) in subparagraph (C)(i), by striking ``or
520(g)'' and inserting ``520(g), 587B, or 587D''; and
(B) in subparagraph (D), by striking ``or 520'' and
inserting ``520, 587B, or 587D''.
(b) Classification of Products.--Section 563 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb-2) is amended by adding at the
end the following:
``(d) Exemption.--This section shall not apply to a product
constituted of only a device and an in vitro clinical test.''.
SEC. 9. RESOURCES.
(a) Findings.--Congress finds that the fees authorized by this
section will be dedicated to meeting the goals identified in the
letters from the Secretary of Health and Human Services to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives,
as set forth in the Congressional Record.
(b) Establishment of User Fee Program.--
(1) Development of user fees for in vitro clinical tests.--
(A) In general.--Beginning not later than October
1, 2025, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall
initiate the development of recommendations in
accordance with this section to present to Congress
with respect to the goals, and plans for meeting the
goals, for the process for the review of in vitro
clinical test submissions and applications under
subchapter J of chapter V of the Federal Food, Drug,
and Cosmetic Act, as added by this Act, for the first 4
fiscal years after fiscal year 2028 and for the
authorization of the In Vitro Clinical Test User Fee
Program for such fiscal years. In developing such
recommendations, the Secretary shall consult with--
(i) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(ii) the Committee on Energy and Commerce
of the House of Representatives;
(iii) scientific and academic experts;
(iv) health care professionals;
(v) representatives of patient and consumer
advocacy groups; and
(vi) the regulated industry.
(B) Prior public input.--Prior to beginning
negotiations with the regulated industry on the
authorization of the In Vitro Clinical Test User Fee
Program, as described in this section, the Secretary
shall--
(i) publish a notice in the Federal
Register requesting public input on the
authorization of user fees;
(ii) hold a public meeting at which the
public may present its views on the
authorization, including specific suggestions
for the recommendations submitted under
subparagraph (E);
(iii) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to the In Vitro
Clinical Test User Fee Program; and
(iv) publish any comments received under
clause (iii) on the website of the Food and
Drug Administration.
(C) Periodic consultation.--Not less frequently
than once every month during negotiations with the
regulated industry, the Secretary shall hold
discussions with representatives of patient and
consumer advocacy groups to continue discussions of the
authorization of the In Vitro Clinical Test User Fee
Program and to solicit suggestions to be included in
the recommendations transmitted to Congress under
subparagraph (F).
(D) Updates to congress.--The Secretary, in
consultation with regulated industry, shall provide
regular updates on negotiations on the reauthorization
of the In Vitro Clinical Test User Fee Program to the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives.
(E) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
(i) present the recommendations developed
under subparagraph (A) to the Committee on
Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce
of the House of Representatives;
(ii) publish such recommendations in the
Federal Register;
(iii) provide for a period of 30 days for
the public to provide written comments on such
recommendations;
(iv) hold a meeting at which the public may
present its views on such recommendations; and
(v) after consideration of such public
views and comments, revise such recommendations
as necessary.
(F) Transmittal of recommendations.--
(i) In general.--Not later than January 15,
2027, the Secretary shall transmit to Congress
the revised recommendations under subparagraph
(A), a summary of the views and comments
received under such subparagraph, and any
changes made to the recommendations in response
to such views and comments.
(ii) Recommendation requirements.--The
recommendations transmitted under this
subparagraph shall--
(I) include the number of full-time
equivalent employees per fiscal year
that are agreed to be hired to carry
out the goals included in such
recommendations for each year of the 5-
year period;
(II) provide that the amount of
operating reserve balance in the user
fee program established under this
section is not more than the equivalent
of 10 weeks of operating reserve;
(III) require the development of a
strategic plan for any surplus within
the operating reserve account above the
10-week operating reserve within 2
years of the establishment of the
program;
(IV) include an operating reserve
adjustment such that, if the Secretary
has an operating reserve balance in
excess of 10 weeks of such operating
reserves, the Secretary shall decrease
such fee revenue and fees to provide
for not more than 10 weeks of such
operating reserves;
(V) if an adjustment is made as
described in subclause (IV), provide
the rationale for the amount of the
decrease in fee revenue and fees shall
be contained in the Federal Register;
and
(VI) provide that the fees assessed
and collected for the full-time
equivalent employees at the Center for
Devices and Radiological Health, with
respect to which the majority of time
reporting data indicates are dedicated
to the process for the review of in
vitro clinical test submissions and
applications under paragraph (5), are
not supported by the funds authorized
to be collected and assessed under
section 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j).
(G) Publication of recommendations.--The Secretary
shall publish on the website of the Food and Drug
Administration the revised recommendations under
subparagraph (F), a summary of the recommendations,
views, and comments received under subparagraphs (B),
(C), and (E), and any changes made to the
recommendations originally proposed by the Secretary in
response to such recommendations, views, and comments.
(H) Minutes of negotiation meetings.--
(i) Public availability.--The Secretary
shall make publicly available, on the website
of the Food and Drug Administration, minutes of
all negotiation meetings conducted under this
subsection between the Food and Drug
Administration and the regulated industry not
later than 30 days after such meeting.
(ii) Content.--The minutes described under
clause (i) shall summarize any substantive
proposal made by any party to the negotiations,
any significant controversies or differences of
opinion during the negotiations, and the
resolution of any such controversy or
difference of opinion.
(2) Establishment of user fee program.--Effective on
October 1, 2028, provided that the Secretary transmits the
recommendations under paragraph (1)(F), the Secretary is
authorized to collect user fees relating to the review of in
vitro clinical test submissions and applications submitted
under subchapter J of chapter V of the Federal Food, Drug, and
Cosmetic Act, as added by this Act, and any other activities or
goals included in recommendations transmitted to Congress
pursuant to this subsection. Fees under such program shall be
assessed and collected only if the requirements under paragraph
(4) are met.
(3) Audit.--
(A) In general.--Beginning 2 years after first
receiving a user fee applicable to submission of an in
vitro clinical test application submitted under
subchapter J of chapter V of the Federal Food, Drug,
and Cosmetic Act, as added by this Act, the Secretary
shall, on a biennial basis, perform an audit of the
costs of reviewing such applications and any other
activities under such subchapter J included in
recommendations transmitted to Congress pursuant to
this subsection. Such an audit shall compare the costs
of reviewing such applications and other activities
under such subchapter J to the amount of the user fee
applicable to such applications and make any necessary
adjustments as described in subparagraph (B).
(B) Alteration of user fee.--The following
adjustments shall apply with respect to audits
performed under subparagraph (A):
(i) If the audit performed 2 years after
first receiving a user fee applicable to
submission of an in vitro clinical test
application described under subparagraph (A)
indicates that the user fees collected for
purposes of such subchapter J exceed 33 percent
of the costs of reviewing such applications and
carrying out activities included in
recommendations transmitted to Congress
pursuant to this subsection, the Secretary
shall alter the user fees applicable to
applications submitted under such subchapter J
such that the user fees do not exceed such
percentage.
(ii) If the audit performed 6 years after
first receiving a user fee applicable to
submission of an in vitro clinical test
application described under subparagraph (A)
indicates that the user fees collected for
purposes of such subchapter J exceed 40 percent
of the costs of reviewing such applications,
and carrying out activities included in
recommendations transmitted to Congress
pursuant to this subsection, the Secretary
shall alter the user fees applicable to
applications submitted under such subchapter J
such that the user fees do not exceed such
percentage.
(iii) If the audit performed 12 years after
first receiving a user fee applicable to
submission of an in vitro clinical test
application described under subparagraph (A),
and any audit performed after such date,
indicates that the user fees collected for
purposes of such subchapter J exceed 49 percent
of the costs of reviewing such applications,
and carrying out activities included in
recommendations transmitted to Congress
pursuant to this subsection, the Secretary
shall alter the user fees applicable to
applications submitted under such subchapter J
such that the user fees do not exceed such
percentage.
(C) Accounting standards.--The Secretary shall
perform an audit under subparagraph (A) in conformance
with the accounting principles, standards, and
requirements prescribed by the Comptroller General of
the United States under section 3511 of title 31,
United States Code, to ensure the validity of any
potential variability.
(D) Implementation requirements.--In the event that
the Secretary fails to promulgate the regulations
described in section 587B(a)(4), 587D(j), or 587S(b)(1)
of the Federal Food, Drug, and Cosmetic Act, as added
by section 3, by the applicable deadline for each such
regulations as described in section 5(a)(2)(A)(ii), the
Secretary shall provide that the user fees applicable
to applications submitted under subchapter J of chapter
V of the Federal Food, Drug, and Cosmetic Act, as added
by section 3, do not exceed 30 percent of the costs of
reviewing such applications.
(4) Conditions.--The user fee program described in this
subsection shall take effect only if the Food and Drug
Administration issues a regulation related to the review
requirements for in vitro diagnostic tests that would be
subject to premarket review under section 587B of the Federal
Food, Drug, and Cosmetic Act, as added by section 3, the review
requirements for test categories eligible for technology
certification under section 587D of such Act, as added by
section 3, and the parameters for the test categories that
would be exempt from any review under subchapter J of chapter V
of such Act.
(5) User fee program definitions and resource
requirements.--
(A) In general.--The term ``process for the review
of in vitro clinical test submissions and
applications'' means the following activities of the
Secretary with respect to the review of in vitro
clinical test premarket and technology certification
applications including supplements for such
applications:
(i) The activities necessary for the review
of premarket applications, premarket reports,
technology certification applications, and
supplements to such applications.
(ii) Actions related to submissions in
connection with in vitro clinical test
development, the issuance of action letters
that allow the marketing of in vitro clinical
tests or which set forth in detail the specific
deficiencies in such applications, reports,
supplements, or submissions and, where
appropriate, the actions necessary to support
the development of in vitro clinical tests.
(iii) The inspection of manufacturing
establishments and other facilities undertaken
as part of the Secretary's review of pending
premarket applications, technology
certifications, and supplements.
(iv) Monitoring of research conducted in
connection with the review of such
applications, supplements, and submissions.
(v) Review of in vitro clinical test
applications subject to section 351 of the
Public Health Service Act (42 U.S.C. 262) and
activities conducted in anticipation of the
submission of such applications for
investigational use under section 587S of the
Federal Food, Drug, and Cosmetic Act (as added
by section 3).
(vi) The development of guidance, policy
documents, or regulations to improve the
process for the review of premarket
applications, technology certification
applications, and supplements.
(vii) The development of voluntary test
methods, consensus standards, or mandatory
performance standards in connection with the
review of such applications, supplements, or
submissions and related activities.
(viii) The provision of technical
assistance to in vitro clinical test developers
in connection with the submission of such
applications, reports, supplements, or
submissions.
(ix) Any activity undertaken in connection
with the initial classification or
reclassification of an in vitro clinical test
in connection with any requirement for approval
or eligibility for an exemption from premarket
review of an in vitro clinical test.
(x) Any activity undertaken in connection
with making a pathway determination of an in
vitro clinical test, including the
identification, establishment, and
implementation of mitigation measures.
(xi) Evaluation of postmarket studies
required as a condition of an approval of a
premarket application of an in vitro clinical
test and ensuring such studies are conducted as
required.
(xii) Any activity undertaken in connection
with ensuring in vitro clinical tests offered
under an exemption from premarket review
pursuant to section 587C or 587G meet the
criteria for such exemption and the applicable
standard.
(xiii) Compiling, developing, and reviewing
information on in vitro clinical tests
necessary to identify issues with the ability
of in vitro clinical tests to meet the
applicable standard, as applicable.
(B) Resource requirements.--Fees collected and
assessed under this section shall be used for the
process for the review of in vitro clinical test
applications, as described in subparagraph (A), and
shall--
(i) be subject to the limitation under
section 738(g)(3) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j(g)(3)), in the
same manner that fees collected and assessed
under section 737(9)(C) of such Act (21 U.S.C.
379i(9)(C)) are subject to such limitation;
(ii) include travel expenses for officers
and employees of the Food and Drug
Administration only if the Secretary determines
that such travel is directly related to an
activity described in subparagraph (A); and
(iii) not be allocated to purposes
described under section 722(a) of the
Consolidated Appropriations Act, 2018 (Public
Law 115-141).
(c) Reports.--
(1) Performance report.--
(A) In general.--
(i) General requirements.--Beginning with
fiscal year 2028, for each fiscal year for
which fees are collected under this section,
the Secretary shall prepare and submit to the
Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on
Energy and Commerce of the House of
Representatives annual reports concerning the
progress of the Food and Drug Administration in
achieving the goals identified in the
recommendations transmitted to Congress by the
Secretary pursuant to subsection (b)(1)(F)
during such fiscal year and the future plans of
the Food and Drug Administration for meeting
the goals.
(ii) Additional information.--Beginning
with fiscal year 2028, the annual report under
this subparagraph shall include the progress of
the Food and Drug Administration in achieving
the goals, and future plans for meeting the
goals, including--
(I) the number of premarket
applications filed under section 587B
of the Federal Food, Drug, and Cosmetic
Act during the applicable fiscal year;
(II) the number of technology
certification applications submitted
under section 587D of the Federal Food,
Drug, and Cosmetic Act during the
applicable fiscal year for each review
division;
(III) the number of breakthrough
designations under section 587I of the
Federal Food, Drug, and Cosmetic Act
during the applicable fiscal year; and
(IV) the number of information
requests requested by the Secretary
pursuant to section 587G(d) of such
Act.
(iii) Real-time reporting.--
(I) In general.--Not later than 30
calendar days after the end of the
second quarter of fiscal year 2028, and
not later than 30 calendar days after
the end of each quarter of each fiscal
year thereafter, the Secretary shall
post the data described in subclause
(II) on the website of the Food and
Drug Administration for such quarter
and on a cumulative basis for such
fiscal year, and may remove duplicative
data from the annual report under this
subparagraph.
(II) Data.--The Secretary shall
post the following data in accordance
with subclause (I):
(aa) The number and titles
of draft and final regulations
on topics related to the
process for the review of in
vitro clinical test submissions
and applications, and whether
such regulations were required
by statute or pursuant to the
recommendations transmitted to
Congress by the Secretary
pursuant to subsection
(b)(1)(F).
(bb) The number and titles
of draft and final guidance on
topics related to the process
for the review of in vitro
clinical test submissions and
applications, and whether such
guidances were issued as
required by statute or pursuant
to the recommendations
transmitted to Congress by the
Secretary pursuant to
subsection (b)(1)(F).
(cc) The number and titles
of public meetings held on
topics related to the process
for the review of in vitro
clinical tests, and if such
meetings were required by
statute or pursuant to the
recommendations transmitted to
Congress by the Secretary
pursuant to subsection
(b)(1)(F).
(iv) Rationale for ivct user fee program
changes.--Beginning with fiscal year 2028, the
Secretary shall include in the annual
performance report under paragraph (1)--
(I) data, analysis, and discussion
of the changes in the number of
individuals hired as agreed upon in the
recommendations transmitted to Congress
by the Secretary pursuant to subsection
(b)(1)(F) and the number of remaining
vacancies, the number of full-time
equivalents funded by fees collected
pursuant to this section, and the
number of full-time equivalents funded
by budget authority at the Food and
Drug Administration by each division
within the Center for Devices and
Radiological Health, the Center for
Biologics Evaluation and Research, the
Office of Regulatory Affairs, and the
Office of the Commissioner;
(II) data, analysis, and discussion
of the changes in the fee revenue
amounts and costs for the process for
the review of in vitro clinical test
submissions and applications, including
identifying--
(aa) drivers of such
changes; and
(bb) changes in the average
total cost per full-time
equivalent in the in vitro
clinical test review program;
(III) for each of the Center for
Devices and Radiological Health, the
Center for Biologics Evaluation and
Research, the Office of Regulatory
Affairs, and the Office of the
Commissioner, the number of employees
for whom time reporting is required and
the number of employees for whom time
reporting is not required; and
(IV) data, analysis, and discussion
of the changes in the average full-time
equivalent hours required to complete
review of each type of in vitro
clinical test application.
(v) Analysis.--For each fiscal year, the
Secretary shall include in the report under
clause (i) an analysis of the following:
(I) The difference between the
aggregate number of premarket
applications filed under section 587B
or section 587D of the Federal Food,
Drug, and Cosmetic Act and the
aggregate number of major deficiency
letters, not approvable letters, and
denials for such applications issued by
the agency, accounting for--
(aa) the number of
applications filed under each
of sections 587B and 587D of
the Federal Food, Drug, and
Cosmetic Act during one fiscal
year for which a decision is
not scheduled to be made until
the following fiscal year; and
(bb) the aggregate number
of applications under each of
sections 587B and 587D of the
Federal Food, Drug, and
Cosmetic Act for each fiscal
year that did not meet the
goals as identified by the
recommendations transmitted to
Congress by the Secretary
pursuant to subsection
(b)(1)(F).
(II) Relevant data to determine
whether the Center for Devices and
Radiological Health has met performance
enhancement goals identified by the
recommendations transmitted to Congress
by the Secretary pursuant to subsection
(b)(1)(F).
(III) The most common causes and
trends for external or other
circumstances affecting the ability of
the Food and Drug Administration to
meet review time and performance
enhancement goals identified by the
recommendations transmitted to Congress
by the Secretary pursuant to subsection
(b)(1)(F).
(B) Publication.--With regard to information to be
reported by the Food and Drug Administration to
industry on a quarterly and annual basis pursuant to
recommendations transmitted to Congress by the
Secretary pursuant to subsection (b)(1)(F), the
Secretary shall make such information publicly
available on the website of the Food and Drug
Administration not later than 60 days after the end of
each quarter or 120 days after the end of each fiscal
year, respectively, to which such information applies.
(C) Updates.--The Secretary shall include in each
report under subparagraph (A) information on all
previous cohorts for which the Secretary has not given
a complete response on all in vitro clinical test
premarket applications and technology certification
orders and supplements, premarket, and technology
certification notifications in the cohort.
(2) Corrective action report.--Beginning with fiscal year
2029, for each fiscal year for which fees are collected under
this section, the Secretary shall prepare and submit a
corrective action report to the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations of the
Senate and the Committee on Energy and Commerce and the
Committee on Appropriations of the House of Representatives.
The report shall include the following information, as
applicable:
(A) Goals met.--For each fiscal year, if the
Secretary determines, based on the analysis under
paragraph (1)(A)(v), that each of the goals identified
by the recommendations transmitted to Congress by the
Secretary pursuant to subsection (b)(1)(F) for the
applicable fiscal year have been met, the corrective
action report shall include recommendations on ways in
which the Secretary can improve and streamline the in
vitro clinical test premarket application and
technology certification review process.
(B) Goals missed.--For each of the goals identified
by the letters described in recommendations transmitted
to Congress by the Secretary pursuant to subsection
(b)(1)(F) for the applicable fiscal year that the
Secretary determines to not have been met, the
corrective action report shall include--
(i) a justification for such determination;
(ii) a description of the types of
circumstances, in the aggregate, under which
applications or reports submitted under
sections 587B and 587D of the Federal Food,
Drug, and Cosmetic Act missed the review goal
times but were approved during the first cycle
review, as applicable;
(iii) a summary and any trends with regard
to the circumstances for which a review goal
was missed; and
(iv) the performance enhancement goals that
were not achieved during the previous fiscal
year and a description of efforts the Food and
Drug Administration has put in place for the
fiscal year in which the report is submitted to
improve the ability of such agency to meet each
such goal for the such fiscal year.
(3) Fiscal report.--
(A) In general.--For fiscal years 2029 and annually
thereafter, not later than 120 days after the end of
each fiscal year during which fees are collected under
this section, the Secretary shall prepare and submit to
the Committee on Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce
of the House of Representatives, a report on the
implementation of the authority for such fees during
such fiscal year and the use, by the Food and Drug
Administration, of the fees collected during such
fiscal year for which the report is made.
(B) Contents.--Such report shall include
expenditures delineated by budget authority and user
fee dollars related to administrative expenses and
information technology infrastructure contracts and
expenditures.
(C) Operating reserve.--Such report shall provide
the amount of operating reserves of carryover user fees
available each year, and any planned allocations or
obligations of such balance of operating reserves for
the program.
(4) Public availability.--The Secretary shall make the
reports required under paragraphs (1) through (3) available to
the public on the website of the Food and Drug Administration.
(5) Enhanced communication.--
(A) Communications with congress.--Each fiscal
year, as applicable and requested, representatives from
the Centers with expertise in the review of in vitro
clinical tests shall meet with representatives from the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives to report on the contents
described in the reports under this section.
(B) Participation in congressional hearing.--Each
fiscal year, as applicable and requested,
representatives from the Food and Drug Administration
shall participate in a public hearing before the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives, to report on the contents
described in the reports under this section. Such
hearing shall occur not later than 120 days after the
end of each fiscal year for which fees are collected
under this section.
SEC. 10. AUTHORIZATION OF APPROPRIATIONS.
For purposes of funding implementation of this Act (including the
amendments made by this Act), including undertaking activities for the
development of regulations and guidances, hiring of necessary staff,
and the development of technology systems to implement this Act
(including the amendments made by this Act) in a timely, effective, and
efficient manner, there is authorized to be appropriated $480,000,000,
to remain available through the end of fiscal year 2028.
SEC. 11. GUIDANCE ON DIAGNOSTIC INNOVATION.
Not later than January 1, 2025, the Secretary shall issue guidance
to assist developers of in vitro clinical tests intended to identify or
diagnose rare diseases and in vitro clinical tests intended to address
an unmet medical need. Such guidance shall include considerations for
addressing barriers to developing sufficient data to demonstrate
clinical validity for such tests, such as challenges associated with
data collection and obstacles to the timely generation of evidence.
SEC. 12. GAO REPORT ON UNIQUE CONSIDERATIONS.
Not later than 3 years after the date of enactment of this Act, the
Comptroller General of the United States shall submit to the Committee
on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives a
report--
(1) evaluating the unique considerations for hospital-based
laboratories, laboratories serving academic medical centers,
and other health care practitioners, as appropriate, in
implementing this Act, including the amendments made by this
Act; and
(2) including recommendations based on the findings of the
report.
SEC. 13. ASSESSMENTS.
Section 1834A(g) of the Social Security Act (42 U.S.C. 1395m-1(g))
is amended by adding at the end the following new paragraph:
``(3) Determinations with respect to in vitro clinical
tests.--On or after the date that is 45 days after the date of
enactment of the VALID Act of 2023, for purposes of determining
whether an in vitro clinical test (as defined in section
201(ss) of the Federal Food, Drug, and Cosmetic Act) is
reasonable and necessary for the diagnosis or treatment of
illness or injury (under section 1862(a)(1)(A)), any assessment
of the analytical validity or clinical validity of such test
shall apply the definitions given such terms in subchapter J of
chapter V of the Federal Food, Drug, and Cosmetic Act.''.
SEC. 14. SEVERABILITY.
If any provision of this Act is declared unconstitutional, or the
applicability of this Act to any person or circumstance is held
invalid, the constitutionality of the remainder of this Act and the
applicability thereof to other persons and circumstances shall not be
affected.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
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