; (9) the test is not a specimen receptacle or instrument; (10) each test report for the test bears a statement that reads as follows: This in vitro clinical test was introduced into commerce prior to the application of the VALID Act and is exempt from FDA premarket review. ; and (11) the developer of the test— (A) maintains documentation demonstrating that the test meets and continues to meet the criteria set forth in this subsection; and (B) makes such documentation available to the Secretary upon request. (b) Exemptions applicable to grandfathered tests An in vitro clinical test that meets the criteria specified in subsection (a) is exempt from premarket review under 587B, labeling requirements under 587L, and test design requirements and quality requirements under 587K, and may be lawfully offered subject to the other applicable requirements of this Act. (c) Modifications In the case of an in vitro clinical test that meets the criteria specified in subsection (a), such test continues to qualify for the exemptions described in subsection (b) if the test is modified and the modification is of a type described in subsection (a)(5), and the person modifying such in vitro clinical test— (1) documents each such modification and maintains documentation of the basis for such determination; (2) provides such documentation relating to the change to the Secretary upon request or inspection