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HHS/FDA | RIN: 0910-AH99 | Publication ID: Spring 2018 |
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 supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Other | |
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 21 U.S.C. 360d 21 U.S.C. 360e 21 U.S.C. 360h 21 U.S.C. 360i 21 U.S.C. 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: 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 |