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HHS/FDA RIN: 0910-AH99 Publication ID: Fall 2021 
Title: Harmonizing and Modernizing Regulation of Medical Device Quality Systems 
Abstract:

FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 820   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 360    21 U.S.C. 360c to 360e    21 U.S.C. 360h to 360j    21 U.S.C. 360l    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 381    21 U.S.C. 383    42 U.S.C. 216 and 262    42 U.S.C. 263a    42 U.S.C. 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2021 
Regulatory Flexibility Analysis Required: Undetermined  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:
Karen Fikes
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 66, Room 5502, Center for Devices and Radiological Health,
Silver Spring, MD 20993
Phone:301 796-9603
Email: karen.fikes@fda.hhs.gov