; and (5) in subsection (g)(2)— (A) by amending the matter preceding subparagraph (A) to read as follows: (2) 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 (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)— (i) by inserting (except for a combination product constituted of a device and an in vitro clinical test) after agency center, ; and (ii) by inserting in vitro clinical test, before or biological product ; and (B) in subparagraph (D)— (i) in the matter preceding clause (i), by striking . If the Secretary determines and inserting , except for a combination product constituted of a device and an in vitro clinical test. For other combination products, if the Secretary determines ; and (ii) in clause (ii)— (I) by inserting or in vitro clinical test after device ; and (II) by inserting and in vitro clinical tests before shall ; (2) in paragraph (3), by striking safety and effectiveness or substantial equivalence and inserting safety and effectiveness, substantial equivalence, or analytical validity and clinical validity before for the approved constituent part ; (3) in paragraph (4)— (A) in subparagraph (A), by striking or 513(f)(2) (submitted in accordance with paragraph (5)) and inserting 513(f)(2) (submitted in accordance with paragraph (5)), 587B, or an exempt test under section 587A, as applicable ; and (B) in subparagraph (B), by inserting or 587B after section 515 ; (4) in paragraph (5)(A), by striking or 510(k) and inserting , 510(k), or 587B