Medical Device Patient Safety Act - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to establish a program to enhance the oversight by the Food and Drug Administration (FDA) of medical device recalls.
Requires the program to routinely and systematically assess: (1) information submitted to the Secretary pursuant to a device recall order issued under the Federal Food, Drug, and Cosmetic Act (FDCA); and (2) information required to be reported by a device manufacturer to the Secretary regarding the manufacturer's correction or removal of a device. Requires the Secretary to use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. Requires such program to be designed to identify such things as recall trends, the causes of recalls, and the time to complete a recall.
Requires the Secretary to develop explicit criteria for assessing whether a person subject to a recall order or the manufacturer's reporting requirement has performed an effective correction or removal action.
Requires the Secretary to document and publish specified information concerning termination of a recall.
Permits the Secretary to conditionally clear for introduction into interstate commerce for commercial distribution a medical device intended for human use if such medical device is cleared pursuant to specified FDCA reporting requirements concerning the introduction of devices into interstate commerce. Permits the Secretary, as part of such conditional clearance, to: (1) impose specified restrictions on the sale, distribution, or use of the device; (2) require specified labeling for the device; and (3) require the maintenance of specified records that enable the FDA to track the device and determine the safety and effectiveness of the device.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5866 Introduced in House (IH)]
112th CONGRESS
2d Session
H. R. 5866
To enhance Food and Drug Administration oversight of medical device
recalls, to provide for the conditional clearance of certain medical
devices, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 30, 2012
Mr. Braley of Iowa introduced the following bill; which was referred to
the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To enhance Food and Drug Administration oversight of medical device
recalls, to provide for the conditional clearance of certain medical
devices, 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.
This Act may be cited as the ``Medical Device Patient Safety Act''.
SEC. 2. OVERSIGHT OF DEVICE RECALLS BY THE FOOD AND DRUG
ADMINISTRATION.
(a) Definitions.--In this Act:
(1) Commissioner.--The term ``Commissioner'' means the
Commissioner of Food and Drugs.
(2) Device.--The term ``device'' has the meaning given that
term in section 201(h) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(h)).
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(b) Actions by Secretary.--To enhance the oversight by the Food and
Drug Administration of device recalls, the Secretary of Health and
Human Services, acting through the Commissioner of Food and Drugs,
shall carry out the activities described in this section.
(c) Assessment of Device Recall Information.--
(1) In general.--
(A) Assessment program.--The Secretary shall
establish a program to routinely and systematically
assess--
(i) information submitted to the Secretary
pursuant to a device recall order under section
518(e) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360h(e)); and
(ii) information required to be reported to
the Secretary regarding a correction or removal
of a device under section 519(g) of such Act
(21 U.S.C. 360i(g)).
(B) Use.--The Secretary shall use the assessment of
information described under subparagraph (A) to
proactively identify strategies for mitigating health
risks presented by defective or unsafe devices.
(2) Design.--The program under paragraph (1) shall be
designed, at a minimum, to identify--
(A) trends in the numbers and types of device
recalls;
(B) the types of devices in each device class that
are most frequently recalled;
(C) the causes of device recalls;
(D) the length of time needed for a person subject
to a device recall to complete the recall;
(E) the length of time needed for the Secretary to
terminate a device recall;
(F) whether the Secretary has performed a device
recall audit check;
(G) which persons have been subject to the most
device recalls; and
(H) any other information as the Secretary
determines appropriate.
(d) Audit Check Procedures.--The Secretary shall clarify procedures
for conducting device recall audit checks to improve the ability of
investigators to perform these checks in a consistent manner.
(e) Assessment Criteria.--The Secretary shall develop explicit
criteria for assessing whether a person subject to a recall order under
section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360h(e)) or to a requirement under section 519(g) of such Act (21
U.S.C. 360i(g)) has performed an effective correction or removal action
under such section 519(g).
(f) Termination of Recalls.--
(1) In general.--The Secretary shall document the basis for
the termination by the Food and Drug Administration of--
(A) an individual device recall ordered under
section 518(e) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360h(e)); and
(B) the requirement on a manufacturer or importer
of a device to report any correction or removal action
for which a report is required to be submitted to the
Secretary under section 519(g) of such Act (21 U.S.C.
360i(g)).
(2) Publication.--
(A) In general.--The Secretary shall, with respect
to each termination described in paragraph (1), publish
the documentation required under such paragraph not
later than 180 days after such termination.
(B) Protection of confidential information or trade
secrets.--Before public disclosure of the documentation
under subparagraph (A), the Secretary shall delete from
the documentation the following:
(i) Any information that constitutes trade
secret or confidential commercial or financial
information.
(ii) Any personnel, medical, or similar
information, including the serial numbers of
implanted devices, which would constitute a
clearly unwarranted invasion of personal
privacy.
SEC. 3. CONDITIONAL CLEARANCE OF CERTAIN MEDICAL DEVICES.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 510
the following:
``SEC. 510A. CONDITIONAL CLEARANCE OF CERTAIN MEDICAL DEVICES.
``(a) In General.--Notwithstanding any other provision of law, the
Secretary may conditionally clear for introduction into interstate
commerce for commercial distribution a medical device intended for
human use if such medical device is cleared pursuant to section 510(k).
``(b) Postclearance Requirements.--As part of the conditional
clearance under subsection (a), the Secretary may impose the following:
``(1) The Secretary may restrict the sale, distribution, or
use of the device but only to the extent that the sale,
distribution, or use of the device may be restricted pursuant
to section 520(e).
``(2) The Secretary--
``(A) may require continuing evaluation and
periodic reporting on the safety, effectiveness, and
reliability of the device for its intended use; and
``(B) shall, to the extent the Secretary makes a
requirement under subparagraph (A), state in the
clearance order the reason or purpose for such a
requirement and the number of patients to be evaluated
and the reports required to be submitted.
``(3) The Secretary may require a prominent display in the
labeling of the device and in the advertising of warnings,
hazards, or precautions important for the device's safe and
effective use, including patient information such as
information provided to the patient on alternative modes of
therapy and on risks and benefits associated with the use of
the device.
``(4) The Secretary--
``(A) may require maintenance of records that will
enable the applicant to submit to the Food and Drug
Administration information needed to trace patients if
such information is necessary to protect the public
health; and
``(B) shall, to the extent the Secretary makes the
requirement under subparagraph (A), require that the
identity of any patient be disclosed in records
maintained under the postclearance reporting
requirements only to the extent required for the
medical welfare of the individual, to determine the
safety or effectiveness of the device, or to verify a
record, report, or information submitted to the agency.
``(5) The Secretary may require maintenance of records for
specified periods of time and organization and indexing of
records into identifiable files to enable the Food and Drug
Administration to determine whether there is reasonable
assurance of the continued safety and effectiveness of the
device.
``(6) The Secretary may require submission of periodic
reports, at specified intervals, which reports shall comply
with the following:
``(A) Identify any of the following changes:
``(i) New indications for use of the
device.
``(ii) Labeling changes.
``(iii) The use of a different facility or
establishment to manufacture, process, or
package the device.
``(iv) Changes in sterilization procedures.
``(v) Changes in packaging.
``(vi) Changes in the performance or design
specifications, circuits, components,
ingredients, principle of operation, or
physical layout of the device.
``(vii) Extension of the expiration date of
the device based on data obtained under a new
or revised stability or sterility testing
protocol.
``(viii) A change that does not affect the
device's safety or effectiveness.
``(B) Contain a summary and bibliography of the
following information not previously submitted:
``(i) Unpublished reports of data from any
clinical investigations or nonclinical
laboratory studies involving the device or
related devices and known to or that reasonably
should be known to the applicant.
``(ii) Reports in the scientific literature
concerning the device and known to or that
reasonably should be known to the applicant.
If, after reviewing the summary and
bibliography, the Food and Drug Administration
concludes that the agency needs a copy of the
unpublished or published reports, the Food and
Drug Administration shall notify the applicant
that copies of such reports should be
submitted.
``(C) Identify changes made pursuant to an
exception or alternative granted under section 801.128
or 809.11 of title 21, Code of Federal Regulations.
``(7) The Secretary may require batch testing of the
device.
``(8) The Secretary may provide for any other requirements
determined by the Secretary to be necessary to provide
reasonable assurance, or continued reasonable assurance, of the
safety and effectiveness of the device.
``(9) The Secretary may require device tracking as provided
under part 821 of title 21, Code of Federal Regulations.
``(c) Rescission of Conditional Clearance.--The Secretary may
rescind the conditional clearance of a medical device under subsection
(a) if the Secretary determines that the conditions imposed on the
clearance of the device described in subsection (b) have not been
met.''.
(b) Civil Monetary Penalties.--Section 303(f)(1)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(1)(A)) is amended by
inserting ``, or a regulation promulgated or an order issued to carry
out this Act,'' after ``any person who violates a requirement of this
Act''.
(c) Process for the Review of Device Applications.--Section
737(8)(J) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379i(8)(J)) is amended by inserting ``or required as a condition of
clearance of a device under section 510A'' after ``Act''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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