Sec. 3201. COVERAGE OF DIAGNOSTIC TESTING FOR COVID-19
231 words·~1 min read·
/statute-compilations/comps-15754/sec-3201A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## 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.” > .
Connectionstraces to 3
Traces to 3 documents
Citation graph
cites case law
Sec. 3201
COVERAGE OF DIAGNOSTIC TESTING FOR COVID-19
Cites 3Cited by 0 across 0 sources