§360g–1 Agency documentation and review of significant decisions regarding devices

Summary

The Secretary must give a clear, written summary of the science and reasons behind any major decision by the FDA’s Center for Devices and Radiological Health about reports under 21 U.S.C. 360(k), classification petitions under 21 U.S.C. 360c(f), applications under 21 U.S.C. 360e, or exemptions under 21 U.S.C. 360j(g). The summary must note important disagreements and how they were resolved, and must briefly say how the “least burdensome” rules under 21 U.S.C. 360c(i)(1)(D), 360c(a)(3)(D), and 360e(c)(5) were considered. If someone asks, the Secretary must give that summary to the person who wants to submit or already submitted the report or application. Any person can ask for a supervisory review of such a decision. The review goes to the next supervisor or higher. The person must ask within 30 days and say if they want an in-person meeting or a teleconference. If requested, the Secretary must set the meeting or call within 30 days and must issue a decision within 45 days of the request, or within 30 days after the meeting or call. These timing rules do not apply when the case is sent to experts outside the FDA.