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 clear under section 510(k), classify under section 513(f)(2), or approve under section 515 and inserting approve under section 587B, exempt from premarket review under section 587C, or grant a technology certification order under section 587D ; and by striking testing devices and inserting in vitro clinical tests ; in subsection (c)(5)— by striking drug or device and inserting drug, device, or in vitro clinical test ; and by striking the drug or the device and inserting the 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 510, 513, and 515, and inserting 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 in vitro clinical test ; and in paragraph (2)— in the heading, by striking and inserting testing devices ; in vitro clinical tests in subparagraphs

(A)and

(B)(other than clause

(iii)of such subparagraph (B)), by striking device each place it appears and inserting in vitro clinical test ; in subparagraph (B)(iii), by striking a device and inserting an in vitro clinical test ; and 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, to be exempted from premarket review under section 587C, or to be offered under a technology certification order under section 587D. ; 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 approving an application under section 587B or granting a technology certification order 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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