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Code · BILL · 116th Congress · S. 3404 (Introduced in Senate) — To amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for o... · Sec. 6

Sec. 6. Emergency use authorization

87 words·~1 min read·/bill/116/s/3404/is/section-6

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Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) is amended— in paragraphs
(1)and (4)(C) of subsection (a), by inserting in vitro clinical test, before or biological product each place such term appears; and in subsection (e)(3)— in subparagraph (B), by striking and at the end; in subparagraph (C), by striking the period and inserting ; and ; and by adding at the end the following: quality system requirements (with respect to in vitro clinical tests) under section 587J. .
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  • 21 USC 360bbb–3
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Sec. 6
Emergency use authorization
Cite21 USC 360bbb–3
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