G/TBT/N/USA/2108  
27 March 2024  
(24-2637) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED STATES OF AMERICA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Food and Drug Administration (FDA), Health and Human Services (HHS) [2140]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the no tification shall be indicated if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Electrical 
stimulation devices intended for self -injurious behavior; Medical equipment (ICS code(s): 
11.040); Domestic safety (ICS code(s): 13 .120)  
5. Title, number of pages and language(s) of the notified document:  Banned Devices; 
Proposal To Ban Electrical Stimulation Devices for Self -Injurious or Aggressive Behavior; 
(16 page(s), in English)  
6. Description of content:  Proposed rule - The Fo od and Drug Administration (FDA, the 
Agency, or we) is proposing to ban electrical stimulation devices (ESDs) intended for self -
injurious behavior (SIB) or aggressive behavior (AB). FDA has determined these devices 
present an unreasonable and substantial r isk of illness or injury that cannot be corrected 
or eliminated by labeling. This proposal follows a court decision vacating a prior ban and 
amendment to the Federal Food, Drug, and Cosmetic Act clarifying our authority to ban 
a device for one or more inte nded uses. This action, if finalized, will mean ESDs for SIB 
and AB are adulterated and not legally marketed.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Prevention of deceptive practices and consumer protection; Protection of 
human health or safety  
8. Relevant documents:   
89 Federal Register (FR) 20882, 26 March 2024; Title 21  Code of Federal Regulations 
(CFR) Parts 882 and 895: 
https://www.govinfo.gov/content/pkg/FR -2024-03-26/html/2024 -06037.htm  
https://www.govinfo.gov/content/pkg/FR -2024-03-26/pdf/2024 -06037.pd f 
This proposed rule is identified by Docket Number FDA -2023-N-3902. The Docket Folder 
is available on Regulations.gov at https://www.regulations. gov/docket/FDA -2023-N-G/TBT/N/USA/2108  
 
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  3902/document  and provides access to primary and supporting documents as well as 
comments received. Documents are also accessible from Regulations.gov  by searching 
the Docket Number. WTO Members and their stakeholders are asked to submit comments 
to the USA TBT Enquiry Point . Comments received by the USA TBT Enquiry Point from 
WTO Members and their stakeholders by 4pm Eastern T ime on 28 May 2024 will be shared 
with the FDA and will also be submitted to the Docket  on Regulations.gov if received 
within the comment period.  
G/TBT/N/USA/1113 and subsequent addenda  - Banned Devices; Proposal To Ban 
Electrical Stimulation Devices Used To Treat Self -Injurious or Aggressive Behavior, 
identified by Docket Number FDA-2016-N-1111. 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  28 May 2024  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2024/TBT/USA/24_02292_00_e.pdf