; and (2) in subsection (e)(3)— (A) in subparagraph (B), by striking and at the end; (B) in subparagraph (C), by striking the period and inserting ; and ; and (C) by adding at the end the following: (D) quality system requirements (with respect to in vitro clinical tests) under section 587J. . 7. Antimicrobial susceptibility tests Section 511A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360a–2 ) is amended— (1) in subsection (a)(1)(C)— (A) 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 (B) by striking testing devices and inserting tests ; (2) in subsection (c)(5), by striking drug or device each place it appears and inserting drug, device, or in vitro clinical test ; (3) in subsection (e)— (A) in the heading, by striking testing devices and inserting In vitro clinical tests ; (B) in paragraph (1)— (i) by striking and 515, and inserting 515, 587B, and 587D ; (ii) by striking antimicrobial susceptibility testing device and inserting antimicrobial susceptibility in vitro clinical test ; and (iii) by striking such device and inserting such test ; (C) in paragraph (2)— (i) in the heading, by striking testing devices and inserting in vitro clinical tests ; and (ii) by amending subparagraph (C) to read as follows: (C) 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 (D) 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 ; (4) in subsection (f), by amending paragraph (1) to read as follows: (1) 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).