; and (iii) in clause (i)(I), by inserting in vitro clinical test, after device, ; and (B) in subparagraph (B), by inserting in vitro clinical test, after device, ; and (3) in subsection (e)(1), by inserting in vitro clinical test, after device, . (n) Office of international relations Section 803 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 383 ) is amended— (1) in subsection (b)— (A) in the matter preceding paragraph (1), by inserting and in vitro clinical tests after devices ; and (B) in paragraph (1), by inserting quality requirements established under section 587J; and at the end; and (2) in subsection (c)— (A) in paragraph (2), by inserting in vitro clinical tests, after devices, ; and (B) in paragraph (4), by inserting or in vitro clinical tests after devices . (o) Recognition of Foreign Government Inspections Section 809(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384e(a)(1) ) is amended by inserting , or section 587I after 510(h) . (p) Food and Drug Administration Section 1003(b)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 393(b)(2) ) is amended— (1) in subparagraph (D), by striking and at the end; (2) in subparagraph (E), by striking the semicolon at the end and inserting ; and ; and (3) by adding at the end the following: (F) in vitro clinical tests are analytically and clinically valid; . (q) Office of Women's Health Section 1011(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399b(b) ) is amended— (1) in paragraph (1), by inserting in vitro clinical tests, after devices, ; and (2) in paragraph (4), by striking and device manufacturers and inserting device manufacturers, and in vitro clinical test developers, . (r) Countermeasure provisions of the PHSA Title III of the PHSA is amended— (1) in section 319F–2(c)(1)(B) (42 U.S.C. 247d–6b(c)(1)(B)) is amended— (A) by striking or device and inserting device