Sec. 5. Transition

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Except as otherwise provided in this section, the amendments made by this Act shall take effect on October 1, 2028 (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 prior to the effective date of this Act.

The Secretary may implement sections 587J and 587U of the Federal Food, Drug, and Cosmetic Act (as added by section 3) beginning on October 1, 2024, and such sections may take effect not earlier than October 1, 2028, to the extent and for the purposes indicated in such sections. In the case of a developer who, between October 1, 2024, and the effective date of this Act, registers under such section 587J with respect to an article that is an in vitro clinical test, such developer shall not be required to register with respect to such article under section 510 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360 ).

The Secretary— shall— within 1 year of the date of enactment of this Act, hold the public meetings described in section 587D(i) of the Federal Food, Drug, and Cosmetic Act (as added by section 3); and within 3 years of the date of enactment of this Act, promulgate final regulations required under the amendments made by this Act; and may take additional actions after the date of enactment that the Secretary determines necessary to ensure an orderly transition, including— establishment of mitigating measures for an in vitro clinical test or category of in vitro clinical tests, which may not take effect until after the effective date described in paragraph (1)(A); and establishment of the comprehensive test information system under section 587T of the Federal Food, Drug, and Cosmetic Act, as added by section 3.

Notwithstanding the date on which guidance or regulations are issued under paragraph

(2)and section 587K of the Federal Food, Drug, and Cosmetic Act, as added by section 3, no guidance or regulations issued pursuant to the amendments made by this Act shall be implemented or take effect until the effective date of this Act, except as otherwise specified in this Act (including the amendments made by this Act). In the event that the Secretary fails to promulgate the regulations required under section 587B(a)(4), 587D(j), or 587S(b)(1) of the Federal Food, Drug, and Cosmetic Act, as added by section 3, by the deadline described in subsection (a)(2)(A)(ii), the Secretary shall, within 15 days of such missed deadline— submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives providing information related to the status of such regulations, including— a rationale for missing the applicable deadline described in such subsection; a description of actions taken to the date of submission of the report to promulgate each such regulations; the expected timeline for promulgating each such regulations; an assessment of the impact of the delay in promulgating such regulations on developers of in vitro clinical tests, including an economic assessment; and an assessment of the impact of the delay in promulgating such regulations on patients; and open a public docket for purposes of soliciting public comments on the impact of the delay in promulgating such regulations. For any in vitro clinical test for which a submission for approval under section 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e ), clearance under section 510(k) of such Act ( 21 U.S.C. 360(k) ), authorization under section 513(f)(2) of such Act ( 21 U.S.C. 360c(f)(2) ), or licensure under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) is pending on the effective date of this Act, including transitional in vitro clinical tests as described in subsection (c), 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 that— is first offered for clinical use during the period beginning on the date that is 45 days after the date of enactment of this Act and ending on the effective date of this Act; or is offered solely for investigational use during the period beginning on the date of enactment of this Act and ending on 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 and performed— in the same clinical laboratory in which the test was developed and for which a certification is still in effect under such section 353 that meets the requirements to perform tests of high complexity; by another laboratory for which a certificate is in effect under such section 353 that meets the requirements to perform tests of high complexity, is within the same corporate organization, and has common ownership by the same parent corporation as the laboratory in which the test was developed; or in the case of a test that was developed by the Centers for Disease Control and Prevention or another laboratory in a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention, by a clinical laboratory for which a certificate is in effect under such section 353 that meets the requirements to perform tests of high complexity, and that is within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention; and when first offered, is not approved under section 515 of the Federal Food, Drug, and Cosmetic Act, cleared under section 510(k) of such Act, authorized under section 513(f)(2) of such Act, subject to a humanitarian device exemption under section 520(m) of such Act ( 21 U.S.C. 360j(m) ), subject to an exemption for investigation use under section 520(g) of such Act ( 21 U.S.C. 360j(g) ), authorized under section 564 of such Act ( 21 U.S.C. 360bbb–3 ), or licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). A transitional in vitro clinical test that is not exempt from premarket review under section 587C of the Federal Food, Drug, and Cosmetic Act, as added by section 3, may continue to be offered, sold, or distributed, as applicable, without marketing authorization until completion of the Secretary’s review of the premarket application or technology certification application under section 587B or 587D, as applicable, if— such in vitro clinical test is a high-risk test (as defined in section 587 of the Federal Food, Drug, and Cosmetic Act, as added by section 3) and the application for such test is submitted not later than 90 days after the effective date of this Act; or such in vitro clinical test is a moderate-risk test (as defined in such section 587), the developer lists the test in accordance with section 587J within 10 calendar days of the effective date of this subchapter, and the application for such test is submitted not later than 1 year after the effective date of this Act. A transitional in vitro clinical test described in paragraph (1)(A)(ii) that is used in a significant risk investigation may continue to be offered for investigational use until completion of the Secretary’s review of an application under 587S, if such application is submitted not later than 90 days after the effective date of this Act. Notwithstanding paragraph (2), a transitional in vitro clinical test that has been approved by the New York State Department of Health may continue to be offered, sold, or distributed, as applicable, after the effective date if— starting on the effective date of this Act, the in vitro clinical test complies with the requirements of subchapter J of the Federal Food, Drug, and Cosmetic Act, as added by this Act, except for section 587B of the Federal Food, Drug, and Cosmetic Act, as added by section 3, and design control provisions of section 587K of such Act; each test report for the test bears a statement of adequate prominence that reads as follows: This in vitro clinical test was developed and first introduced prior to the effective date of the ; VALID Act of 2023 . This test was approved by the New York State Department of Health, but the test has not been reviewed by the Food and Drug Administration. a premarket application under section 587B of the Federal Food, Drug, and Cosmetic Act, as added by section 3, or technology certification application under section 587D of such Act, as added by section 3, is submitted no later than— 5 years after the effective date of this Act, if the in vitro clinical test is approved by the New York State Department of Health as a genetic testing molecular test, a microbiology molecular test, an oncology molecular test, or any other type of molecular test; or 2 years after the effective date of this Act, if the in vitro clinical test is approved by the New York State Department of Health as a type of test not described in clause (i); and a test in compliance with this paragraph may continue to be offered, sold, or distributed, as applicable, until the completion of the Secretary’s review of the premarket application or technology certification application described in subparagraph (C). Beginning on the effective date of this Act— any in vitro clinical test with a premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e ) or a licensure under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) is deemed to be approved pursuant to an application under section 587B(a) of the Federal Food, Drug, and Cosmetic Act, as added by this Act; and any in vitro clinical test (as so defined) that was cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) ) or authorized under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(f)(2) ) is deemed to be approved pursuant to an application under section 587B(b) of the Federal Food, Drug, and Cosmetic Act, as added by this Act. Any in vitro clinical test that has an investigational device exemption in effect under section 520(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j(g) ) is deemed to have an investigational use exemption in effect under section 587S of such Act, as added by this Act, beginning on the effective date of this Act. Any in vitro clinical test that has an approved humanitarian device exemption under section 520(m) of such Act is deemed to have a humanitarian test exemption under section 587A(g) of such Act, as added by this Act, beginning on the effective date of this Act. Any in vitro clinical test that has received a breakthrough device designation under section 515B(e)(1)(D) of such Act ( 21 U.S.C. 360e–3(e)(1)(D) ) is deemed to have a breakthrough in vitro clinical test designation under section 587C of such Act, as added by this Act, beginning on the effective date of this Act. With regard to any in vitro clinical test that is the subject of a pre-submission request described in the guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q–Submission Program , issued by the Food and Drug Administration on January 6, 2021, such request is deemed to constitute a request for informal feedback under section 587F of the Federal Food, Drug, and Cosmetic Act, as added by section 3, beginning on the effective date of this Act. Notwithstanding section 587 of the Federal Food, Drug, and Cosmetic Act, as added by section 3, for purposes of subchapter J of chapter V of such Act, as added by section 3, the following apply: In the case of an in vitro clinical test type that has been classified by the Secretary as a class I device pursuant to section 513 of such Act ( 21 U.S.C. 360c ), such in vitro clinical test shall be low-risk, unless the in vitro clinical test is a test described in the second sentence of section 510(l)(1) of such Act or the test is redesignated by the Secretary pursuant to section 587F of such Act. In the case of an in vitro clinical test type that has been classified by the Secretary as a class II device pursuant to section 513 of such Act ( 21 U.S.C. 360c ), such in vitro clinical test shall be moderate-risk, unless inaccurate results from the test would be immediately life threatening or the test is redesignated by the Secretary pursuant to section 587F of such Act. In the case of an in vitro clinical test type that has been classified by the Secretary as a class III device pursuant to section 513 of such Act ( 21 U.S.C. 360c ) or an in vitro clinical test licensed pursuant to section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), such in vitro clinical test shall be high-risk, unless redesignated by the Secretary pursuant to section 587F of the Federal Food, Drug, and Cosmetic Act.

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