; and (D) in the matter following paragraph (7) by striking or 520(g) each place it appears and inserting , 520(g) or 587R ; 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. . (g) Optimizing global clinical trials Section 569A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8a(b)) is amended by inserting an in vitro clinical test, as defined in subsection (ss) of such section, before or a biological product . (h) 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 . (i) Regulations and hearings Section 701(h)(1)(C)(ii) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 371(h)(1)(C)(ii) ) is amended by inserting and in vitro clinical tests after devices . (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 ; (2) in subsection (a)(1), in the third sentence, by striking or chapter IX and inserting section 587R or chapter IX ; (3) 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 ; (4) by inserting in vitro clinical test, after device, each place it appears; (5) after making the amendments in paragraphs (1) and (2), by inserting in vitro clinical tests, after devices, each place it appears