; (2) in subsection (a)(1), in the fourth sentence, by striking or chapter IX and inserting section 587S, section 587M, section 587N, or chapter IX ; (3) after making the amendments in paragraphs (1) and (2), by inserting in vitro clinical tests, after devices, each place it appears; (4) in subsection (a)(2)(B)— (A) by inserting or in vitro clinical tests after prescribe or use devices ; and (B) by inserting or in vitro clinical tests after process devices ; (5) by inserting in vitro clinical test, after device, each place it appears; (6) in subsection (e), by inserting , or section 587M, 587N, or 587S, after section 519 or 520(g) ; (7) in subsection (f)(3)— (A) in subparagraph (A), by striking or at the end; (B) in subparagraph (B), by striking the period at the end and inserting ; or ; and (C) after subparagraph (B), by inserting the following: (C) is accredited under section 587Q. ; and (8) by adding at the end the following: (i) For purposes of this section, the term establishment includes a laboratory performing an in vitro clinical test. . (k) Publicity Section 705(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 375(b) ) is amended by inserting in vitro clinical tests, after devices, . (l) Presumption Section 709 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379a ) is amended by inserting in vitro clinical test, after device, . (m) Listing and certification of color additives for foods, drugs, and cosmetics Section 721(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379e(a) ) is amended— (1) in the matter preceding paragraph (1), by inserting or in vitro clinical tests after or devices ; and (2) in the flush text following paragraph (2)— (A) by inserting or an in vitro clinical test after a device ; and (B) by inserting or in vitro clinical tests after devices . (n) Imports and exports Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ) is amended— (1) in subsection (a)— (A) by inserting in vitro clinical tests, after devices, each place it appears