Sec. 70309. Coverage of in vitro diagnostic products

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Section 6001 of division F of the Families First Coronavirus Response Act ( Public Law 116–127 ) is amended— by amending subsection (a)(1) to read as follows: Qualified in vitro diagnostic products and the administration of such in vitro diagnostic products. ; and in subsection (d)— by striking and inserting the following: Terms.— The terms Terms.— In this section: The terms ; and by adding at the end the following: The term qualified in vitro diagnostic product means an in vitro diagnostic product (as defined in section 809.3(a) of title 21, Code of Federal Regulations) for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19 that is approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) , 360c, 360e, and 360bbb–3).

Such term includes an in vitro diagnostic test that— subject to subparagraph (C), is developed and used in a laboratory certified to perform high-complexity testing pursuant to section 353 of the Public Health Service Act ( 42 U.S.C. 263a ) and with respect to which such laboratory— validates prior to use for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19, including by obtaining confirmation of validation using an assay authorized under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ); notifies the Secretary of such use; and includes a statement together with the results of the test that reads:

This test has not been FDA cleared or approved. This test has been authorized by FDA under an emergency use authorization for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens ; is developed and used in a laboratory certified to perform high-complexity testing pursuant to section 353 of the Public Health Service Act ( 42 U.S.C. 263a ) and such laboratory— is operating under an authorization of the State (as defined in section 2 of the Public Health Service Act ( 42 U.S.C. 201 )) in which such laboratory is located and such State has notified the Secretary of its intention to review tests intended to diagnose SARS–CoV–2 or diagnose the virus that causes COVID–19 to be used in such State; has notified the Secretary of such use for such purpose in such State; and includes a statement together with the results of the test that reads:

This test was developed for use as a part of a response to the public health emergency declared to address the outbreak of COVID–19. This test has not been reviewed by the Food and Drug Administration ; or is developed by a commercial test manufacturer that, with respect to such test— validates such test prior to use to detect SARS–CoV–2 or diagnose the virus that causes COVID–19, including by obtaining confirmation of validation using an assay authorized under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ); notifies the Secretary of such use; and includes a statement together with the results of the test that reads:

(i)or

(iii)of subparagraph

(B)if— the emergency use authorization request submitted by a laboratory or manufacturer described in such respective clause with respect to such test has been denied; or such laboratory or manufacturer does not submit such a request within 15 business days of the notification under subclause

(II)of such respective subparagraph. . Subparagraph

(B)of section 1905(a)(3) of the Social Security Act ( 42 U.S.C. 1396d(a)(3) ), as added by section 6004(a)(1) of division F of the Families First Coronavirus Response Act) is amended to read as follows: qualified in vitro diagnostic products (as defined in section 6001(d) of division F of the Families First Coronavirus Response Act) and the administration of such in vitro diagnostic products; .

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