; 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 ; (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 combination 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), or 587B