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HHS/FDA RIN: 0910-AH99 Publication ID: Spring 2020 
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 manufactures, 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 
EO 13771 Designation: Deregulatory 
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  10/00/2020 
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:
Ian Ostermiller
Regulatory Counsel, Center for Devices and Radiological Health
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 66, Room 5454,
Silver Spring, MD 20993
Phone:301 796-5678
Email: ian.ostermiller@fda.hhs.gov