Sec. 5. Transition
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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. The Secretary shall, prior to the date on which the amendments made by this Act generally apply pursuant to paragraph (1)— 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; within 2 years of the date of enactment of this Act promulgate regulations required under sections 587L, 587M, 587V, and 587W; issue final guidance on premarket review requirements under section 587B, technology certification review requirements under section 587D, and applicability under section 587A; and promulgate additional regulations required by such amendments made by this Act. Notwithstanding the date on which guidance or regulations are issued under paragraph (2), no guidance or regulations issued pursuant to the amendments made by this Act shall take effect until the effective date of this Act, as described in paragraph (1), except as otherwise provided for transitional tests. Except as provided in subsection (d), for any product or test that is an in vitro clinical test as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by this Act, the following authorities shall apply: An in vitro clinical test that meets the criteria for a grandfathered test as set forth in section 587A(c)(2) of the Federal Food, Drug, and Cosmetic Act, as added by section 3, may continue to be offered for clinical use and shall be subject only to applicable provisions of section 353 of the Public Health Service Act and section 587A(a)(4) of the Federal Food, Drug, and Cosmetic Act, as added by section 3. Before any product or test that is an in vitro clinical test as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by this Act, is first offered, sold, or distributed after the date of enactment of this Act, but prior to 90 days before the effective date of this Act, such product or test shall be considered a transitional test as described under subsection
(d)and comply with the applicable device provisions of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) and the Public Health Service Act ( 42 U.S.C. 201 et seq.). For any product or test that is an in vitro clinical test as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by this Act, for which a submission for marketing authorization under section 515, clearance under section 510(k), authorization under section 513(f)(2), approval under section 520(m), or emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e , 360(k), 360c(f)(2), 360j(m), 360bbb–3) or approval under the Public Health Service Act ( 42 U.S.C. 201 et seq.) is pending on the effective date of this Act, the Secretary may review and take action on such submission after the effective date of this Act according to the statutory provision under which such submission was submitted. For purposes of this paragraph, the term transitional in vitro clinical test means an in vitro clinical test, as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by this Act, that— was developed by a clinical laboratory certified by the Secretary under section 353 of the Public Health Service Act ( 42 U.S.C. 263a ) that meets the requirements for performing high-complexity testing for use only within that certified laboratory or another laboratory within the organization under common ownership; does not have an approval under section 515, a clearance under section 510(k), an authorization under section 513(f)(2), an approval under section 520(m), or an emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e , 360(k), 360c(f)(2), 360j(m), 360bbb–3) or approval under the Public Health Service Act ( 42 U.S.C. 201 et seq.); and is first offered for clinical use during the period beginning on the date of enactment of this Act and ending on the implementation date of this Act. Notwithstanding subsection (c), a transitional in vitro clinical test may continue to be offered for clinical use until the effective date of this Act, as described in subsection (b)(1), except that the Secretary retains authority to enforce the device provisions of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) and the Public Health Service Act ( 42 U.S.C. 201 et seq.) for any specific transitional in vitro clinical test, or any type of transitional in vitro clinical test, as the Secretary determines necessary to protect the public from a serious risk to health. A transitional in vitro clinical test that is the subject of an application for premarket review under section 587B of the Federal Food, Drug, and Cosmetic Act or technology certification application under section 587D of such Act, as added by this Act, that is submitted within 90 days of the effective date of this Act may continue to be offered, sold, or distributed until completion of the Secretary’s review of the premarket application or technology certification application. Any in vitro clinical test (as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by this Act) with a premarket approval under section 515, a clearance under section 510(k), an authorization under section 513(f), or a licensure under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) is deemed to have an approved application under section 587B of the Federal Food, Drug, and Cosmetic Act, as added by this Act, beginning on the later of— the effective date of this Act; or such other date, not later than 3 years after such effective date, as the person responsible for the device selects. Any in vitro clinical test (as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by this Act) that has an approved investigational device exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j(g) ) is deemed to have an approved investigational use under section 587Q of such Act, as added by this Act, beginning on the effective date of this Act. An instrument (as defined in section 587 of the Federal Food, Drug, and Cosmetic Act, as added by this Act) that was purchased prior to the date of enactment of this Act and was not cleared, authorized, or approved by the Food and Drug Administration or part of an instrument family that was cleared, authorized, or approved by the Food and Drug Administration at the time of purchase may continue to be used by the purchaser to develop and introduce into interstate commerce an in vitro clinical test during the period beginning on the date of enactment of this Act and ending 5 years after such date of enactment. Beginning at the end of such period, any new in vitro clinical test that is developed and introduced into interstate commerce shall be based on an instrument (as defined in section 587(11) of the Federal Food, Drug, and Cosmetic Act, as added by section 3) that complies with the requirements of the Federal Food, Drug, and Cosmetic Act, as amended by this Act. This section applies notwithstanding section 587A(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act, as added by this Act.
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