; and (B) by inserting in the case of an in vitro clinical test, the test does not conform to the applicable requirements of section 587K, or after requirements of section 520(f), or ; (2) in subsection (d)(3)— (A) in subparagraph (A)— (i) in the matter preceding clause (i), by inserting and no component of an in vitro clinical test or other article of in vitro clinical test that requires further processing, after health-related purposes ; (ii) in clause (i), by striking drug or device and inserting drug, device, or in vitro clinical test ; 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, ; (3) in subsection (e)(1), by inserting in vitro clinical test, after device, ; and (4) in subsection (o)— (A) by inserting or in vitro clinical test after device ; and (B) by inserting , or under section 587J of each foreign establishment, after section 510(i) of each establishment . (o) 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 striking , and and inserting and quality requirements established under section 587K; and ; 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 . (p) 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 of foreign establishments registered under section 587J, after 510(h) . (q) 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