; and (iii) by striking such device and inserting such in vitro clinical test ; and (C) in paragraph (2)— (i) in the heading, by striking testing devices and inserting in vitro clinical tests ; (ii) 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 ; (iii) in subparagraph (B)(iii), by striking a device and inserting an in vitro clinical test ; and (iv) 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, to be exempted from premarket review under section 587C, or to be offered under a technology certification order under section 587D. ; (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). ; and (5) in subsection (g)(2)— (A) by amending the matter preceding subparagraph (A) to read as follows: (2) with respect to approving an application under section 587B or granting a technology certification order under section 587D— ; and (B) in subparagraph (A)— (i) by striking device and inserting in vitro clinical test ; and (ii) by striking antimicrobial susceptibility testing device and inserting antimicrobial susceptibility in vitro clinical test . 8. Combination products (a) In general Section 503(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g) ) is amended— (1) in paragraph (1)— (A) in subparagraph (A), by striking or biological product and inserting in vitro clinical test (except for a product constituted of a device and an in vitro clinical test), or biological product