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FDA is updating the 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 Act (FD&C Act) to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is taking this action to put into place the procedures and timeframes that apply to supervisory review of significant decisions pertaining to devices. This regulation will also provide procedures and a timeframe for requesting internal agency supervisory review of other types of decisions made by CDRH not addressed in the FDASIA requirements.  These actions will improve FDA’s accountability and regulatory certainty with respect to CDRH’s significant decisions with respect to devices.