; (D) in paragraph (5), by striking or 520(g) and inserting , 520(g), or 587S ; and (E) in the matter following paragraph (7) by striking or 520(g) each place it appears and inserting , 520(g), or 587S ; and (4) by amending subsection (e) to read as follows: (e) Definitions In this section, the terms investigational drug , investigational device , investigational in vitro clinical test , treatment investigational new drug application , treatment investigational device exemption , and treatment investigational in vitro clinical test exemption shall have the meanings given the terms in regulations prescribed by the Secretary. . (f) Optimizing global clinical trials Section 569A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8a(b)) is amended— (1) by striking subsection each place it appears and inserting paragraph ; and (2) by inserting an in vitro clinical test, as defined in paragraph (ss) of such section, before or a biological product . (g) Patient participation in medical product discussion The heading of subsection (a) of section 569C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8c ) is amended by striking drugs and devices and inserting drugs, devices, and in vitro clinical tests . (h) Regulations and hearings Clause (ii) of section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 371(h)(1)(C) ) is amended— (1) by inserting and in vitro clinical tests after devices ; and (2) by moving the margin of such clause 2 ems to the left. (i) Records Section 703 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 373 ) is amended— (1) by inserting in vitro clinical tests, after devices, each place such term appears; and (2) by inserting in vitro clinical test, after device, each place such term appears. (j) Factory inspection Section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 ) (other than subsection (g)) is amended— (1) by striking drugs or devices each place it appears and inserting drugs, devices, or in vitro clinical tests