Regulatory Counsel, Center for Devices and Radiological Health

0910-AH99 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Harmonizing and Modernizing Regulation of Medical Device Quality Systems

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.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage No No Other 21 CFR 820 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 No NPRM 04/00/2019 Undetermined No Undetermined No No No No Ian Ostermiller Regulatory Counsel, Center for Devices and Radiological Health 0910 Food and Drug Administration FDA 301 796-5678 ian.ostermiller@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring MD 20993