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HHS/FDA RIN: 0910-AI22 Publication ID: Fall 2019 
Title: 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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Not subject to, not significant 
CFR Citation: 21 CFR 882.5235    21 CFR 895.105   
Legal Authority: 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   
Legal Deadline:  None
Action Date FR Cite
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 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Ian Ostermiller
Regulatory Counsel, Center for Devices and Radiological Health
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 66, Room 5454,
Silver Spring, MD 20993
Phone:301 796-5678