View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AH37 Publication ID: Spring 2018 
Title: 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. 

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
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 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   
Legal Deadline:  None
Action Date FR Cite
NPRM  01/17/2018  83 FR 2388   
NPRM Comment Period End  04/17/2018 
Final Action  05/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
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
10903 New Hampshire Avenue, WO 66, Room 5574, Center for Devices and Radiological Health,
Silver Spring, MD 20993
Phone:240 402-0768