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HHS/FDA RIN: 0910-AI84 Publication ID: Spring 2025 
Title: Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior 
Abstract:

This final rule would ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA intends to review the comments received and assess any new data or information in connection with making a determination as to whether the use of ESDs for SIB and AB presents an unreasonable and substantial risk of illness or injury and that the risks associated with ESDs for these intended uses cannot be corrected or eliminated by labeling. If FDA makes this determination again, the Agency will issue a final rule to ban these devices. This rule is authorized by section 516 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360f).

 
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 14192 Designation: Not subject to, not significant 
CFR Citation: 21 CFR 882.5235    21 CFR 895   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 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
Timetable:
Action Date FR Cite
NPRM  03/26/2024  89 FR 20882   
NPRM Comment Period End  05/28/2024 
Final Rule  05/00/2026 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Patricia Kaufman
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 66,
Silver Spring, MD 20993
Phone:301 796-1174
Email: patricia.kaufman@fda.hhs.gov