21 U.S.C. § 360g–1 — Agency documentation and review of significant decisions regarding devices

(a) Documentation of rationale for significant decisions. (1) The FDA must write a substantive summary explaining the scientific and regulatory reasoning behind any major decision by its device center (the Center for Devices and Radiological Health) about a 510(k) submission, a classification petition, a premarket approval application, or an investigational device exemption application. This summary must document any significant disagreements that came up and how they were resolved. (2) The FDA must give this summary, on request, to whoever is submitting or has submitted the report or application. (3) The summary must also include a short statement on how the FDA considered and applied the "least burdensome" approach required by other listed sections. (b) Review of significant decisions. (1) Anyone can request a supervisory review of a significant decision described above — meaning a review by the next level of supervisor above the person who made the decision, or higher. (2) That request must be submitted to the FDA within 30 days of the decision, and must say whether the person wants an in-person meeting or a phone/video review. (3)(A) Unless the exception below applies, the FDA must schedule the requested review within 30 days of the request, and must issue its decision within 45 days of the request — or, if a meeting was held, within 30 days after that meeting. (B) That 45/30-day deadline doesn't apply when the case is referred to outside experts.