in vitro clinical test that was offered, sold, or distributed as a restricted device prior to the enactment date of this subchapter shall continue to comply with the applicable restrictions imposed under section 515 or section 520(e) until the effective date of restrictions issued under subsection (a). 587O. Appeals (a) Significant decision (1) In general The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission of an application for, or a review of, an in vitro clinical test under section 587B or section 587D or regarding an exemption under section 587A, including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion. (2) Provision of documentation Upon request, the Secretary shall furnish a substantive summary described in paragraph (1) to the person who has made, or is seeking to make, a submission described in such paragraph. (3) Application of least burdensome requirements The substantive summary required under this subsection shall include a brief statement regarding how the least burdensome requirements were considered and applied consistent with section 587B(j), as applicable. (b) Review of significant decisions (1) Request for supervisory review of significant decision Any person may request a supervisory review of the significant decision described in subsection (a)(1). Such review may be conducted at the next supervisory level or higher above the agency official who made the significant decision. (2) Submission of request A person requesting a supervisory review under paragraph (1) shall submit such request to the Secretary not later than 30 days after the decision for which the review is requested and shall indicate in the request whether such person seeks an in-person meeting or a teleconference review. (3) Timeframe The Secretary shall schedule an in-person or teleconference review, if