Regulatory Counsel, Center for Devices and Radiological Health

0910-AI22 201910 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 Banned Devices; Final Ban on Electrical Stimulation Devices Used for Self-Injurious and Aggressive Behavior

FDA is finalizing a ban on electrical stimulation devices used to treat self-injurious or aggressive behavior. FDA has determined that these devices present substantial and unreasonable risks of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No Not subject to, not significant 21 CFR 882.5235 21 CFR 895.105 21 U.S.C. 351 and 352 21 U.S.C. 360 21 U.S.C. 360c 21 U.S.C. 360e 21 U.S.C. 360f 21 U.S.C. 360i 21 U.S.C. 360j 21 U.S.C. 371 No NPRM 04/25/2016 81 FR 24385 NPRM Comment Period End 05/25/2016 NPRM Comment Period Extended 05/23/2016 81 FR 32258 NPRM Comment Period Extended End 07/25/2016 Final Rule 12/00/2019 No No None 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