; and (C) 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 ). (2) Premarket review or technology certification 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— (A) 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