; (II) providing an opportunity for public comment for a period of not less than 30 calendar days; and (III) after consideration of any comments submitted, publishing a final administrative order in the Federal Register; and (ii) may establish mitigating measures with respect to a category in a premarket approval order or technology certification order. (2) In vitro clinical tests previously approved, cleared, or exempted as devices (A) In general Any special controls or restrictions applicable to an in vitro clinical test with the same indications for use pursuant to section 587(10) based on prior regulation as a device approved under section 515, cleared or exempt under section 510(k), or classified under section 513(f)(2), including any such special controls or restrictions established during the period beginning on the date of enactment of the Verifying Accurate Leading-edge IVCT Development Act of 2020 and ending on the effective date of such Act (as described in section 5(b) of such Act)— (i) shall continue to apply to such approved, cleared, or exempted in vitro clinical test after such effective date; and (ii) are deemed to be mitigating measures as of the effective date of such approval, clearance, or exemption. (B) Changes The Secretary may establish, change, or withdraw mitigating measures for such a test or indications for use the procedures under paragraph (1). (b) Documentation (1) 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— (A) in accordance with section 587B(c)(2)(G)(i), submit documentation to the Secretary as part of the application for the test under subsection (c) or (d) of section 587B demonstrating that such mitigating measures have been met; (B) if such application is approved, maintain documentation demonstrating that such mitigating measures continue to be met following a test modification by the developer