the Public Health Service Act ( 42 U.S.C. 201 et seq.). (3) Tests under review beginning on or after the date of enactment of this act but prior to implementation 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. (c) Application of authorities to transitional and grandfathered In vitro clinical tests (1) Definition 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— (A) 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