  
  
G/TBT/N/USA/1113/Add.2  
12 March 2020  
(20-1934) Page: 1/1 
Committee on Technical Barriers to Trade  Original:  English  
 
  NOTIFICATION  
Addendum  
The following communication, dated 12 March 2020, is being circulated at the request of the 
delegation of the United States of America .  
 
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TITLE: Banned Devices; Electrical Stimulation Devices for Self -Injurious or Aggressive Behavior  
AGENCY: Food and Drug Administration, HHS  
ACTION: Final rule  
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is finalizing a ban on 
electrica l stimulation devices (ESDs) for self -injurious or aggressive behavior. FDA has determined 
that these devices present an unreasonable and substantial risk of illness or injury that cannot be 
corrected or eliminated by labeling. This ban includes both new d evices and devices already in 
distribution and use; however, this ban provides transition time for those individuals currently 
subject to ESDs for the identified intended use to transition off ESDs under the supervision of a 
physician.  
DATES: This rule is effective 6 April 2020. However, compliance for devices currently in use and 
subject to a physician -directed transition plan is required on 2 September 2020. Compliance for all 
other devices is required on 6 April 2020.  
The docket folder on Regulations.gov  provides access to primary and supporting documents for 
this rulemaking as well as the comments received:  
https://www.regulations.gov/docket?D=FDA -2016-N-1111. 
https://www.govinfo.gov/content/pkg/FR -2020-03-06/html/2020 -04328.htm   
https://www.govinfo.gov/content/pkg/FR -2020-03-06/pdf/2020 -04328.pdf   
https://members.wto.org/crnattachments/2020/TBT/USA/20_1887 _00_e.pdf  
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