G/TBT/N/USA/1934  
20 October 2022  
(22-7875) 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) [1965]  
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 [  ], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other  [X]: To allow FDA to better protect the public health by preventing re -importation 
and deterring future shipments of refused medical devices subject to administrative 
destruction.  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medical 
devices: Instruments and appliances used in medical, surgical, dental or veterinary 
sciences, including scintigraphic apparatus, other  electro -medical apparatus and sight -
testing instruments (HS code(s): 9018); 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:  Medical Devices 
Subject to Admi nistrative Destruction; (9 page(s), in English)  
6. Description of content:  Notice of Proposed Rulemaking - The Food and Drug 
Administration (FDA, Agency, or we) is proposing a regulation to implement its new 
authority to destroy a device valued at $2,500 or less (or such higher amount as the 
Secretary of the Treasury may set by regulation), that has been refused admission into 
the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act 21 USC Ch. 
9), by providing to the owner or consignee notice and an opportunity to appear and 
introduce testimony prior to the destruction. Once finalized, this regulation will allow FDA 
to better protect the public health by preventing re -importation and deterring future 
shipments of refused devices subject to administrative destruction. We also discuss in 
this Notice of Proposed Rulemaking our intent to change FDA's procedures for 
administrative destructi on of drugs and, if this proposed rule is finalized, these procedures 
will also include devices subject to administrative destruction. We described our current 
procedures in the proposed and final rules entitled "Administrative Destruction of Certain 
Drugs  Refused Admission to the United States."  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/USA/1934  
 
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  8. Relevant documents:   
87 Federal Register (FR) 60947, 7 October 2022; Title 21 Code of Federal Regulations 
(CFR) Part 1:  
https://www.govinfo.gov/content/pkg/FR -2022-10-07/html/2022 -21809.htm  
https://www.govinfo.gov/content/pkg/FR -2022-10-07/pdf/2022 -21809.pdf  
This notice of proposed rulemaking is identified by Docket Number FDA -2021-N-1348. 
The Docket Folder is available on Regulations.gov at 
https://www.regulations.gov/docket/FDA -2021-N-1348/document  and provides access 
to primary 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 co mments to the USA TBT Enquiry Point  by or before 4pm Eastern 
Time on 6 December 2022. Comments received by the USA TBT Enquiry Point from WTO 
Members and their stakeholders will be shared with the regulator and will also be 
submitted to the Docket  on Regulations.gov if received within the comment period.  
FDA Administrative Destruction of Certain Drugs Refused Admission to the United States; 
Proposed and Final Rules (Primary Documents), Comments, Supporting Materials are 
available from Regulations.gov : FDA-2014-N-0504. 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  6 December 2022  
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/2022/TBT/USA/22_7094_00_e.pdf