; and (B) by inserting or an in vitro clinical test (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(ss) )) after Act ( 21 U.S.C. 321(h) )) ; (2) in section 319F–1(a)(2) (42 U.S.C. 247d–6a(a)(2)), by inserting an in vitro clinical tests (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(ss) )), before or device ; and (3) in section 319F–3(i)(7) (42 U.S.C. 247d–6d(i)(7)), by inserting an in vitro clinical tests (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(ss) )), before or device . 5. Transition (a) Implementation (1) In general Except as otherwise provided in this section, the amendments made by this Act apply beginning on the first day of the fourth fiscal year that begins after the date of enactment of this Act (in this section and in subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this Act, referred to in this section as the effective date of this Act ), except that the Secretary of Health and Human Services (in this section referred to as the Secretary ) may take the actions described in paragraph (2) as described in such paragraph, and may take such other actions, and expend such funds, as the Secretary determines necessary to ensure an orderly transition. (2) Actions The Secretary shall, prior to the date on which the amendments made by this Act generally apply pursuant to paragraph (1)— (A) within 2 years of the date of enactment of this Act hold the public meetings described in subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by section 3; (B) within 2 years of the date of enactment of this Act promulgate regulations required under sections 587L, 587M, 587V, and 587W; (C) issue final guidance on premarket review requirements under section 587B, technology certification review requirements under section 587D, and applicability under section 587A