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

Summary

The Secretary must give a plain summary explaining the science and rules behind any big decision by the Center for Devices and Radiological Health about a device report, a petition to change a device’s classification, an application for approval, or a request for an exemption. The summary must note any major disagreements and how they were settled. If asked, the Secretary must give that summary to the person who is trying to submit or who already submitted the report or application. The summary must also say briefly how the agency considered using the least burdensome approach. Anyone 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 if the person wants an in-person meeting or a teleconference. If asked, the agency must schedule the meeting or teleconference within 30 days and must send a decision within 45 days of the request, or within 30 days after the meeting or teleconference. These timing rules do not apply when the matter is sent to experts outside the FDA.