Sec. 6. Emergency use authorization

458 words·~2 min read·/bill/118/hr/2369/ih/section-6

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Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) is amended— by inserting or developer after manufacturer , each place such term appears; in subsection (a)— in paragraphs

(1)and (4)(C), by inserting in vitro clinical test, before or biological product each place such term appears; in paragraph (2)(A), by striking or 515 and inserting 515, or 587B ; and by adding at the end the following: The terms develop and developer , with respect to an in vitro clinical test, have the meanings given such terms in section 587. ; in subsection (b), by inserting or developer after manufacturer each place such term appears; in subsection (e)— by inserting or developers after manufacturers each place such term appears; in paragraph (2)(B)(ii), by inserting or develop after not manufacture ; in paragraph (3)— in subparagraph (A), by striking or 520(f)(1) and inserting , 520(f)(1), or 587V ; in subparagraph (B), by striking and at the end; in subparagraph (C), by striking the period and inserting or 587O; and ; and by adding at the end the following: quality requirements (with respect to in vitro clinical tests) under section 587K. ; and in paragraph (4)— in subparagraph (A), by striking ; or and inserting a semicolon; in subparagraph (B), by striking the period and inserting ; or ; and by adding at the end the following: with respect to in vitro clinical tests, requirements applicable to restricted in vitro clinical tests pursuant to section 587O. ; in subsection (k), by striking or 520(g) and inserting 520(g), or 587S ; and in subsection (m)— in the subsection heading, by striking inserting Laboratory tests associated with devices after in vitro clinical tests ; and devices in paragraph (1)— by striking to a device and inserting to an in vitro clinical test ; and by striking such device and inserting such in vitro clinical test . Section 564A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3a ) is amended— in subsection (a)— in paragraph (2), by inserting in vitro clinical test, after device, ; and by adding at the end the following: The term developer , with respect to an in vitro clinical test, has the meaning given such term in section 587. ; by inserting or developer after manufacturer each place it appears; and in subsection (c)(1)— by inserting or quality requirements after good manufacturing practice requirements ; and by striking or 520(f)(1) and inserting , 520(f)(1), or 587K . Section 564B(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3b(2)) is amended— in subparagraph (A), by striking or 515 and inserting 515, or 587B ; and in subparagraph (B), by striking or 520 and inserting 520, or 587S.

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3 references not yet in our index

21 USC 360bbb–3
21 USC 360bbb–3a
21 USC 360bbb–3b(2)

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cites case law

Sec. 6

Emergency use authorization

Cite21 USC 360bbb–3

Cite21 USC 360bbb–3a

Cite21 USC 360bbb–3b(2)

Cites 3Cited by 0 across 0 sources