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HHS/FDA | RIN: 0910-AH99 | Publication ID: Spring 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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Economically 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 |
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Timetable:
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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 |