COVERAGE OF DIAGNOSTIC TESTING FOR COVID-19.

SEC. 3201. COVERAGE OF DIAGNOSTIC TESTING FOR COVID-19. Paragraph (1) of section 6001(a) of division F of the Families First Coronavirus Response Act (Public Law 116-127)is amended to read as follows: “(1) An in vitro diagnostic test defined in section 809.3 of title 21, Code of Federal Regulations (or successor regulations) for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19, and the administration of such a test, that— “(A) 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, 360bbb-3); “(B) the developer has requested, or intends to request, emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3), unless and until the emergency use authorization request under such section 564 has been denied or the developer of such test does not submit a request under such section within a reasonable timeframe; “(C) is developed in and authorized by a State that has notified the Secretary of Health and Human Services of its intention to review tests intended to diagnose COVID-19; or “(D) other test that the Secretary determines appropriate in guidance.” .