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HHS/FDA RIN: 0910-AI84 Publication ID: Spring 2023 
Title: ●Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior 
Abstract:

The Food and Drug Administration (FDA) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA finalized a ban on these devices in 2020, but the D.C. Circuit vacated the final rule in 2021. FDA previously determined that 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. Now that Congress has removed the statutory basis for the D.C. Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices.  

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
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  12/00/2023 
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