Sec. 7. Antimicrobial susceptibility tests

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Section 511A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360a–2 ) is amended— in subsection (a)(1)(C)— by striking or approve under section 515 and inserting approve under section 515, or approve, exempt, or issue a technology certification order under subchapter J ; and by striking testing devices and inserting tests ; in subsection (c)(5), by striking drug or device each place it appears and inserting drug, device, or in vitro clinical test ; in subsection (e)— in the heading, by striking and inserting testing devices ;

In vitro clinical tests in paragraph (1)— by striking and 515, and inserting 515, 587B, and 587D ; by striking antimicrobial susceptibility testing device and inserting antimicrobial susceptibility in vitro clinical test ; and by striking such device and inserting such test ; in paragraph (2)— in the heading, by striking and inserting testing devices ; and in vitro clinical tests by amending subparagraph

(C)to read as follows: The antimicrobial susceptibility in vitro clinical test meets all other requirements to be approved under section 587B or exempted from premarket review under section 587D. ; and after making the amendments in subparagraphs (B)(ii), (B)(iii), and (C)(ii), by striking device each place it appears and inserting in vitro clinical test ; in subsection (f), by amending paragraph

(1)to read as follows: The term antimicrobial susceptibility in vitro clinical test means an in vitro clinical test that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs). ; and in subsection (g)(2)— by amending the matter preceding subparagraph

(A)to read as follows: with respect to clearing under section 510(k), classifying under section 513(f)(2), approving under section 515 or section 587B, or exempting from approval requirements under section 587D— ; and in subparagraph (A)— by striking device and inserting in vitro clinical test ; and by striking antimicrobial susceptibility testing device and inserting antimicrobial susceptibility in vitro clinical test .

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21 USC 360a–2

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Sec. 7

Antimicrobial susceptibility tests

Cite21 USC 360a–2

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