FDA Updates Procedures to Request Supervisory Review of Certain Decisions Concerning Medical Devices

Today, the U.S. Food and Drug Administration (FDA) issued a final rule Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health to amend its regulations regarding  internal agency supervisory review of certain decisions related to medical devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic (FD&C) Act, the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). As of August 1, 2019, the effective date of the final rule, the FDA will update the Center for Devices and Radiological Health Appeals Processes and Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A guidance documents to ensure consistency with current policies, procedures and timelines for the request of FDA supervisory review of certain decisions made by the Center for Devices and Radiological Health.

Read the Final Rule