Right to Test Act
This bill authorizes a state's public health department, or another entity designated by the state's governor, to approve a diagnostic test or diagnostic device (e.g., a test for the virus that causes COVID-19, or coronavirus disease 2019) for use during a public health emergency.
Unless requested by the governor of the state, the Food and Drug Administration (FDA) may not, during the emergency, engage in certain enforcement actions related to such a test or device.
Not later than 180 days following the end of the public health emergency, the FDA must review and make a final determination concerning approval of the test or device.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7017 Introduced in House (IH)]
<DOC>
116th CONGRESS
2d Session
H. R. 7017
To allow States to approve the use of diagnostic tests during a public
health emergency.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 26, 2020
Mr. McHenry (for himself, Mr. Murphy of North Carolina, and Mr. Roy)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To allow States to approve the use of diagnostic tests during a public
health emergency.
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 ``Right to Test Act''.
SEC. 2. STATE APPROVAL OF DIAGNOSTIC TESTS.
(a) In General.--Notwithstanding chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) and section 353 of the
Public Health Service Act (42 U.S.C. 263a), during any public health
emergency declared by the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') under section 319 of
the Public Health Service Act (42 U.S.C. 247d) or by a State in
accordance with the law of the State, the public health department of
such State (or such other State entity as designated by the Governor of
the State) may clear or approve diagnostic tests or diagnostic devices,
for use in that State during the applicable public health emergency
only.
(b) Application.--An approval or clearance pursuant to subsection
(a) may--
(1) allow for the preparation, compounding, assembly,
propagation, manufacture, development, sale, distribution, or
use of a specified diagnostic test or diagnostic device to
address the health diagnostic needs of the State during the
public health emergency;
(2) apply to a diagnostic test or diagnostic device needed
to address the health diagnostic needs of the State during the
public health emergency, as determined by the State, including,
but not limited to, a test or device that uses reagents or
swabbing (including self-swab);
(3) apply to the testing of patients if the State certifies
that the test can be validated, as determined by the State; and
(4) apply to laboratory-developed tests performed by
laboratories and hospitals certified under section 353 of the
Public Health Service Act (42 U.S.C. 263a), and to such tests
performed by clinical laboratory companies.
(c) Suspension Enforcement by FDA.--
(1) In general.--Except as provided in paragraph (1), with
respect to a diagnostic test or diagnostic device approved or
cleared by a State pursuant to subsection (a), the Secretary
may not, for the duration of the applicable public health
emergency engage in any enforcement action--
(A) with respect to the test or device, to the
extent that such test or device is distributed and used
within the State granting the approval or clearance in
accordance with the requirements of the State;
(B) against a State or State entity that clears or
approves the test or device in accordance with this
section; or
(C) against any State, entity of a State, health
care provider, health care facility, laboratory,
educational institution, manufacturer, or distributor
that prepares, propagates, compounds, assembles, or
processes a diagnostic test or diagnostic device by
chemical, physical, biological, or other procedure for
such test or device or develops, manufactures,
distributes, sells, administers, or evaluates such
test--
(i) within the applicable State in
accordance with the requirements of the State;
or
(ii) for the applicable State or
individuals or entities that are located within
the applicable State.
(2) Exception.--The provisions of paragraph (1) shall not
apply with respect to a State if the Governor of the State
requests that enforcement continue in the State during the
public health emergency.
(d) Action by FDA After Public Health Emergency.--Not later than
180 days after the end of any public health emergency under which a
State exercises its authority under subsection (a) with respect to a
diagnostic test or diagnostic device, if the Food and Drug
Administration has not cleared or approved such test or device under
chapter V of the Federal Food, Drug, and Cosmetic Act, the Secretary
shall review and make a final determination, within such 180-day
period, with respect to such test or device for clearance or approval.
(e) Diagnostic Tests and Diagnostic Devices.--In this section, the
terms ``diagnostic test'' and ``diagnostic device'' include in vitro
diagnostic products, laboratory developed tests, viral tests,
serological and antibody tests, and any other test used to identify,
analyze, or investigate a disease.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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