; and (B) by adding at the end the following: (3) Developer The term developer , with respect to an in vitro clinical test, has the meaning given such term in section 587. ; (2) by inserting or developer after manufacturer each place it appears; and (3) in subsection (c)(1)— (A) by inserting or quality requirements after good manufacturing practice requirements ; and (B) by striking or 520(f)(1) and inserting , 520(f)(1), or 587K . (c) Products held for emergency use Section 564B(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3b(2)) is amended— (1) in subparagraph (A), by striking or 515 and inserting 515, or 587B ; and (2) in subparagraph (B), by striking or 520 and inserting 520, or 587S. 7. Antimicrobial susceptibility tests Section 511A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360a–2 ) is amended— (1) in subsection (a)(1)(C)— (A) by striking clear under section 510(k), classify under section 513(f)(2), or approve under section 515 and inserting approve under section 587B, exempt from premarket review under section 587C, or grant a technology certification order under section 587D ; and (B) by striking testing devices and inserting in vitro clinical tests ; (2) in subsection (c)(5)— (A) by striking drug or device and inserting drug, device, or in vitro clinical test ; and (B) by striking the drug or the device and inserting the drug, device, or in vitro clinical test ; (3) in subsection (e)— (A) in the heading, by striking testing devices and inserting In vitro clinical tests ; (B) in paragraph (1)— (i) by striking 510, 513, and 515, and inserting 587B, and 587D ; (ii) by striking antimicrobial susceptibility testing device and inserting antimicrobial susceptibility in vitro clinical test ; 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