; (2) in subsection (a)— (A) in paragraphs (1) and (4)(C), by inserting in vitro clinical test, before or biological product each place such term appears; (B) in paragraph (2)(A), by striking or 515 and inserting 515, or 587B ; and (C) by adding at the end the following: (F) The terms develop and developer , with respect to an in vitro clinical test, have the meanings given such terms in section 587. ; (3) in subsection (b), by inserting or developer after manufacturer each place such term appears; (4) in subsection (e)— (A) by inserting or developers after manufacturers each place such term appears; (B) in paragraph (2)(B)(ii), by inserting or develop after not manufacture ; (C) in paragraph (3)— (i) in subparagraph (A), by striking or 520(f)(1) and inserting , 520(f)(1), or 587V ; (ii) in subparagraph (B), by striking and at the end; (iii) in subparagraph (C), by striking the period and inserting or 587O; and ; and (iv) by adding at the end the following: (D) quality requirements (with respect to in vitro clinical tests) under section 587K. ; and (D) in paragraph (4)— (i) in subparagraph (A), by striking ; or and inserting a semicolon; (ii) in subparagraph (B), by striking the period and inserting ; or ; and (iii) by adding at the end the following: (C) with respect to in vitro clinical tests, requirements applicable to restricted in vitro clinical tests pursuant to section 587O. ; (5) in subsection (k), by striking or 520(g) and inserting 520(g), or 587S ; and (6) in subsection (m)— (A) in the subsection heading, by striking Laboratory tests associated with devices inserting in vitro clinical tests after devices ; and (B) in paragraph (1)— (i) by striking to a device and inserting to an in vitro clinical test ; and (ii) by striking such device and inserting such in vitro clinical test . (b) Emergency use of medical products Section 564A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3a ) is amended— (1) in subsection (a)— (A) in paragraph (2), by inserting in vitro clinical test, after device,