Regulatory Counsel

0910-AH99 202204 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Devices; Quality System Regulation Amendments

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.

]]> Economically Significant Previously Published in The Unified Agenda Long-Term Actions Yes No 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 02/24/2022 87 FR 10119 NPRM Comment Period End 05/24/2022 Next Action Undetermined To Be Determined Undetermined No Undetermined No No No No Rachael Hunt Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-5244 rachael.hunt@fda.hhs.gov 10903 New Hampshire Avenue, Building 66, Center for Devices and Radiological Health, Silver Spring MD 20993