; and (ii) are deemed to be mitigating measures as of the effective date specified in section 5(a)(1)(A) of the VALID Act of 2023 . (B) Changes Notwithstanding subparagraph (A), the Secretary may establish, change, or withdraw mitigating measures for such tests or category of tests using the procedures under paragraph (1). (b) Documentation (1) In vitro clinical tests subject to premarket review The developer of an in vitro clinical test subject to premarket review under section 587B and to which mitigating measures apply shall maintain documentation in accordance with the applicable quality requirements under section 587K and make such documentation available to the Secretary upon request or inspection. (2) Other tests The developer of an in vitro clinical test that is offered under a technology certification order or other exemption from premarket review under section 587B and to which mitigating measures apply shall— (A) maintain documentation in accordance with the applicable quality requirements under section 587K demonstrating that such mitigating measures continue to be met following a test modification by the developer; (B) make such documentation available to the Secretary upon request or inspection; and (C) include in the performance summary for such test a brief description of how such mitigating measures are met, if applicable. 587F. Regulatory pathway designation (a) Pathway determinations (1) In general After considering available evidence with respect to an in vitro clinical test or category of in vitro clinical tests with the same intended use, including the identification, establishment under paragraph (4), and implementation of mitigating measures under section 587E, as appropriate, the Secretary may, upon the initiative of the Secretary or upon request of a developer, determine that— (A) such in vitro clinical test is high-risk and subject to premarket review under section 587B