II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Right to Test Act’’. 

5 SEC. 2. STATE APPROVAL OF DIAGNOSTIC TESTS. 

6 (a) IN GENERAL.—Notwithstanding chapter V of the 

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

8 et seq.) and section 353 of the Public Health Service Act 

9 (42 U.S.C. 263a), during any public health emergency de10 clared by the Secretary of Health and Human Services 


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1 (referred to in this section as the ‘‘Secretary’’) under sec2 tion 319 of the Public Health Service Act (42 U.S.C. 

3 247d) or by a State in accordance with the law of the 

4 State, the public health department of such State (or such 

5 other State entity as designated by the governor of the 

6 State) may clear or approve diagnostic tests or diagnostic 

7 devices, for use in that State during the applicable public 

8 health emergency only. 

9 (b) APPLICATION.—An approval or clearance pursu10 ant to subsection (a) may— 

11 (1) allow for the preparation, compounding, as12 sembly, propagation, manufacture, development, 

13 sale, distribution, or use of a specified diagnostic 

14 test or diagnostic device to address the health diag15 nostic needs of the State during the public health 

16 emergency; 

17 (2) apply to a diagnostic test or diagnostic de18 vice needed to address the health diagnostic needs of 

19 the State during the public health emergency, as de20 termined by the State, including, but not limited to, 

21 a test or device that uses reagents or swabbing (in22 cluding self-swab); 

23 (3) apply to the testing of patients if the State 

24 certifies that the test can be validated, as deter25 mined by the State; and 


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1 (4) apply to laboratory-developed tests per2 formed by laboratories and hospitals certified under 

3 section 353 of the Public Health Service Act (42 

4 U.S.C. 263a), and to such tests performed by clin5 ical laboratory companies. 

6 (c) SUSPENSION ENFORCEMENT BY FDA.— 

7 (1) IN GENERAL.—Except as provided in para8 graph (1), with respect to a diagnostic test or diag9 nostic device approved or cleared by a State pursu10 ant to subsection (a), the Secretary may not, for the 

11 duration of the applicable public health emergency 

12 engage in any enforcement action— 

13 (A) with respect to the test or device, to 

14 the extent that such test or device is distributed 

15 and used within the State granting the approval 

16 or clearance in accordance with the require17 ments of the State; 

18 (B) against a State or State entity that 

19 clears or approves the test or device in accord20 ance with this section; or 

21 (C) against any State, entity of a State, 

22 health care provider, health care facility, labora23 tory, educational institution, manufacturer, or 

24 distributor that prepares, propagates, com25 pounds, assembles, or processes a diagnostic 


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1 test or diagnostic device by chemical, physical, 

2 biological, or other procedure for such test or 

3 device or develops, manufactures, distributes, 

4 sells, administers, or evaluates such test— 

5 (i) within the applicable State in ac6 cordance with the requirements of the 

7 State; or 

8 (ii) for the applicable State or individ9 uals or entities that are located within the 

10 applicable State. 

11 (2) EXCEPTION.—The provisions of paragraph 

12 (1) shall not apply with respect to a State if the gov13 ernor of the State requests that enforcement con14 tinue in the State during the public health emer15 gency. 

16 (d) ACTION BY FDA AFTER PUBLIC HEALTH EMER17 GENCY.—Not later than 180 days after the end of any 

18 public health emergency under which a State exercises its 

19 authority under subsection (a) with respect to a diagnostic 

20 test or diagnostic device, if the Food and Drug Adminis21 tration has not cleared or approved such test or device 

22 under chapter V of the Federal Food, Drug, and Cosmetic 

23 Act, the Secretary shall review and make a final deter24 mination, within such 180-day period, with respect to such 

25 test or device for clearance or approval. 


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1 (e) DIAGNOSTIC TESTS AND DIAGNOSTIC DE2 VICES.—In this section, the terms ‘‘diagnostic test’’ and 

3 ‘‘diagnostic device’’ include in vitro diagnostic products, 

4 laboratory developed tests, viral tests, serological and anti5 body tests, and any other test used to identify, analyze, 

6 or investigate a disease. 

Æ 


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