; (B) in subparagraph (B), by adding at the end the following: For purposes of this Act, a product that constitutes a combination of a device and an in vitro clinical test is not a combination product within the meaning of this subsection and an in vitro clinical test that is offered as a separate product intended to inform the use of a drug, biological product, or device is not a combination product within the meaning of this subsection. ; and (C) in subparagraph (D)(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 587D ; and (B) in subparagraph (C), by striking or 515 and inserting 515, or 587B, or that is under an order under section 587D ; (4) in paragraph (5)(A), by striking or 510(k) and inserting , 510(k), 587B, or 587D ; (5) in paragraph (7), by striking or substantial equivalence and inserting , substantial equivalence, or analytical validity and clinical validity ; (6) in paragraph (8), by adding at the end the following: (I) This paragraph shall not apply to a product constituted of a device and an in vitro clinical test. ; and (7) in paragraph (9)— (A) in subparagraph (C)(i), by striking or 520(g) and inserting 520(g), 587B, or 587D