§360g–1 Agency Documentation and Review of Significant Decisions Regarding Devices

Summary

The Secretary must give a clear, written summary explaining the scientific and regulatory reasons behind any important decision by the FDA’s Center for Devices and Radiological Health about certain device reports, classification petitions, applications, or exemption requests. The summary must note any major disagreements about the decision and say how those disagreements were resolved. If someone asks, the Secretary must give that summary to the person who is seeking to submit or who already submitted the report or application. The summary must also briefly explain how the “least burdensome” approach was considered and applied. Anyone affected can ask for a supervisory review of the decision. The request must be sent to the Secretary within 30 days of the decision and must say whether the person wants an in-person meeting or a teleconference. If asked, the Secretary must schedule the meeting or call within 30 days of the request and must issue a decision to the requester within 45 days of the request, or within 30 days after the meeting or call. These timing rules do not apply when the matter is sent to experts outside the FDA.