Sec. 3201. Coverage of diagnostic testing for COVID–19
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/bill/116/hr/748/eas/section-3201·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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(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: 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— 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); 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; 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 other test that the Secretary determines appropriate in guidance. .
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- 21 USC 360bbb–3
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Sec. 3201
Coverage of diagnostic testing for COVID–19
Cite21 USC 360bbb–3
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