Regulatory Counsel, Center for Devices and Radiological Health

0910-AH99 202010 The Regulatory Plan and the 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 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.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No Deregulatory 21 CFR 820 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 No NPRM 02/00/2021 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