G/TBT/N/USA/2071  
1 December 2023  
(23-8175) 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) [2102]  
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):  Wound 
dressings and liquid wound washes containing antimicrobials and/or other chemicals as 
solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and 
liquid wound washes; Medical equipment (ICS code(s): 11.040); Wound dressings and 
compresses (ICS code(s): 11.120.20); F irst aid (ICS code(s): 11.160)  
5. Title, number of pages and language(s) of the notified document:  Medical Devices; 
General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; 
Wound Dressings Formulated as a Gel, Creams, or Ointm ent; and Liquid Wound Washes; 
(29 page(s), in English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA, 
Agency, or we) are proposing to classify certain types of wound dressings and liquid 
wound washes containing antimicro bials and/or other chemicals (unclassified, 
preamendments devices) as solid wound dressings; wound dressings formulated as a gel, 
cream, or ointment; and liquid wound washes. FDA currently regulates these unclassified 
devices as devices requiring premarket  notification (510(k) requirements), with the 
product codes FRO, GER, MGP, MGQ, and EFQ, but FDA intends to create new product 
codes for these proposed classifications upon finalization of this classification action. FDA 
is proposing to classify certain wo und dressings and liquid wound washes containing 
antimicrobials with a high level of antimicrobial resistance (AMR) concern (i.e., medically 
important antimicrobials) into class III. In addition, FDA is proposing to classify certain 
wound dressings and liq uid wound washes containing antimicrobials with a medium or 
low level of AMR concern and/or other chemicals, into class II (subject to special controls 
and 510(k) requirements).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/USA/2071  
 
- 2 - 
 
  8. Relevant documents:   
88 Federal Register (FR) 83774, 30 November 2023; Title 21 Code of Federal Regulations 
(CFR) Part 878 : 
https://www.govinfo.gov/content/pkg/FR -2023-11-30/html/2023 -26209.htm  
https://www.govinfo.gov/content/pkg/FR -2023-11-30/pdf/2023 -26209.pdf  
This proposed rule is identified by Docket Number FDA -2023-N-3392. The Docket Folder 
is available on Regulations.gov at https://www.regulations.gov/docket/FDA -2023-N-
3392/document  and provides access to primary and supporting documents as well as 
comments received. Documents are also accessible fr om Regulations.gov  by searching 
the Docket Number. WTO Members and their stakeholders are asked to submit comments 
to the USA TBT Enquiry Po int by or before 4pm Eastern Time  on 28 February 2024. 
Comment s 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.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  28 February 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/20 23/TBT/USA/23_13920_00_e.pdf