; or (B) 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. (3) Investigational use request 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. (4) Tests approved by New York State 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— (A) 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; (B) 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.