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HHS/FDA RIN: 0910-AH37 Publication ID: Fall 2017 
Title: Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health  
Abstract:

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 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. 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.  These actions will improve FDA’s accountability and regulatory certainty with respect to CDRH’s significant decisions with respect to devices. 

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 10.75    21 CFR 800.75   
Legal Authority: 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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Adaeze Teme
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Health and Human Services, 10903 New Hampshire Avenue, Buliding 66, Room 5574,
Silver Spring, MD 20993
Phone:240 402-0768
Email: adaeze.teme@fda.hhs.gov