Sec. 5. Transition
1,208 words·~5 min read·
/bill/117/hr/4128/ih/section-5A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Except as otherwise provided in this section, the amendments made by this Act apply 4 years 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 ). The Secretary of Health and Human Services (in this section referred to as the Secretary ) may take the actions described in paragraph (2), and may 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 1 year 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 final regulations required under sections 587B, 587D, 587L, 587M, 587V, and 587W; and within 2 years of the date of enactment of this Act issue final guidance on applicability requirements under section 587A.
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 under this section. Except as provided in subsections
(c)and (d), for any 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 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 the effective date of this Act, such product or test shall be considered a transitional test as described under subsection
(c)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 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 section, 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— is offered for clinical use during the period beginning on the date of enactment of this Act and ending on the date that is 90 days after the effective date of this Act; is 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; and is not approved under section 515, cleared under section 510(k), authorized under section 513(f)(2), subject to an exemption under section 520(m), or authorized 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. ). 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 prior to 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.
Connectionstraces to 6
Citation graph
cites case law
Cites 6Cited by 0 across 0 sources