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HHS/FDA RIN: 0910-AH99 Publication ID: Fall 2023 
Title: Medical Devices; Quality System Regulation Amendments 
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: Section 3(f)(1) Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  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  02/24/2022  87 FR 10119   
NPRM Comment Period End  05/24/2022 
Final Rule  12/00/2023 
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:
Laurie Sternberg
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-630), 10903 New Hampshire Avenue, Building 66, Room 5517,
Silver Spring, MD 20993
Phone:240 402-0425
Email: laurie.sternberg@fda.hhs.gov