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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3769 Introduced in Senate (IS)]

<DOC>

116th CONGRESS
  2d Session
                                S. 3769

To allow States to approve the use of diagnostic tests during a public 
                           health emergency.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              May 19, 2020

     Mr. Cruz (for himself, Mr. Braun, Mrs. Loeffler, and Mr. Lee) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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>
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