Regulatory Counsel

0910-AH37 201810 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health

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.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage Undetermined No Deregulatory 21 CFR 10.75 21 CFR 800.75 5 U.S.C. 551 to 558 5 U.S.C. 701 to 706 15 U.S.C. 1451 to 1461 21 U.S.C. 141 to 149 21 U.S.C. 321 to 397 21 U.S.C. 467(f) 21 U.S.C. 679 21 U.S.C. 821 21 U.S.C. 1034 28 U.S.C. 2112 42 U.S.C. 201 42 U.S.C. 262 42 U.S.C. 263(b) 42 U.S.C. 264 No NPRM 01/17/2018 83 FR 2388 NPRM Comment Period End 04/17/2018 Final Action 06/00/2019 No No None No No No No Adaeze Teme Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-0768 adaeze.teme@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Room 5574, Center for Devices and Radiological Health, Silver Spring MD 20993