Regulatory Counsel

0910-AH37 201610 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 proposing to implement 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 codify the procedures and timeframes that apply to supervisory review of significant decisions pertaining to devices. The FDA is also proposing regulations to 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.

]]> Routine and Frequent Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 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 161 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 11/00/2016 No No Undetermined No No No No Karen Fikes Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 karen.fikes@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301, Silver Spring MD 20993