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HHS/FDA RIN: 0910-AI22 Publication ID: Spring 2020 
Title: Banned Devices; Final Ban on Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior 
Abstract:

FDA is finalizing a ban on electrical stimulation devices for 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: Completed Actions 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Fully or Partially Exempt 
CFR Citation: 21 CFR 882.5235    21 CFR 895   
Legal Authority: 21 U.S.C. 360f    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
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  03/06/2020  85 FR 13312   
Final Rule Effective  04/06/2020 
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
Email: ian.ostermiller@fda.hhs.gov