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

In today’s Federal Register, FDA is proposing to update regulations governing internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic (FD&C) Act. The proposed rule describes the procedures required for any person to request supervisory review of any significant decisions made by an FDA employee within the Center for Devices and Radiological Health (CDRH). The proposed rule, if finalized, will reflect the recommendations provided in the guidance document “Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A” and will follow the procedures and timeframes under the Federal Food, Drug, and Cosmetic Act, the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act).  Within this proposed rule, FDA is also defining “significant decisions” and providing new procedural requirements for requesting supervisory review within CDRH of other types of decisions made by CDRH that are not addressed in FDASIA and the Cures Act. This action is intended to enhance transparency and predictability while achieving our public health mission. We welcome your comments and suggestions regarding this proposed rule. The comment period will be open for 90 days (until April 17, 2018). If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or atdice@fda.hhs.gov. Food and Drug Administration Center for Devices and Radiological Health