; and (B) in the case of such a test that is introduced or delivered for introduction into interstate commerce after the date of enactment of the Verifying Accurate Leading-edge IVCT Development Act of 2020 , the labeling of such test bears the following statement: This product is intended solely for further development of an in vitro clinical test and is exempt from FDA regulation. This product must be evaluated by the in vitro clinical test developer if it is used with or in the development of an in vitro clinical test. . (c) Grandfathered tests (1) Exemption An in vitro clinical test that meets the criteria set forth in paragraph (2) is exempt from the requirements of this subchapter, except as provided under section 587A(a)(4), the registration and listing requirements under section 587I, and the adverse reporting requirements under section 587L, and may be lawfully marketed subject to the other applicable requirements of this Act, if— (A) each test report template 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 date of enactment of the Verifying Accurate Leading-edge IVCT Development Act of 2020 and has not been reviewed by the Food and Drug Administration. ; and (B) the developer of the test— (i) maintains documentation demonstrating that the test meets and continues to meet the criteria set forth in paragraph (2); and (ii) makes such documentation available to the Secretary upon request. (2) Criteria for exemption An in vitro clinical test is exempt as specified in paragraph (1) if the test— (A) (i) was first offered for clinical use by such laboratory before the date of enactment of the Verifying Accurate Leading-edge IVCT Development Act of 2020 ; (ii) was developed by a clinical laboratory for which a certificate is in effect under section 353 of the Public Health Service Act that meets the requirements under section 353 for performing high-complexity testing