Regulatory Counsel

0910-AH67 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Amendments and Repeal to Medical Device Software Regulations

The 21st Century Cures Act amended the definition of device under the Federal Food, Drug, and Cosmetic Act to exclude certain medical software functions from the definition of device and therefore FDA’s jurisdiction. FDA will revise its regulations to be consistent with this statutory change.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No Deregulatory 21 CFR 862.2100 21 CFR 880.6310 21 CFR 892.2010 21 U.S.C. 321 21 U.S.C. 351 21 U.S.C. 360.21 21 U.S.C. 371 No Direct Final Rule 10/00/2018 No None No No No No Erica Payne Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3999 301 847-8145 erica.payne@fda.hhs.gov Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517, Silver Spring MD 20993