G/TBT/N/USA/1031/Rev.1  
24 September 2020  
(20-6489) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
Revision  
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 (Articles 3.2 and 7.2):   
2. Agency responsible:  Food and Drug Administration (FDA)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be indicated if differe nt 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 [   ], other :   
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading.  ICS numbers may be provided in addition, where applicable):  Tobacco 
products regulated as drugs, devices, or combination products; TOBACCO AND 
MANUFACTURED TOBACCO SUBSTITUTES (HS 24); Pharmaceutics  (ICS 11.120), 
Tobacco, tobacco products and related equipment (ICS 65.160)  
5. Title, number of pages and language(s) of the notified document:  Regulations 
Regarding "Intended Uses" (12 page(s), in English)  
6. Description of content:  The Food and Drug Ad ministration (FDA, the Agency, or we) is 
proposing to amend its medical product "intended use" regulations. This action, if 
finalized, will amend FDA's regulations describing the types of evidence relevant to 
determining whether a product is intended for u se as a drug or device under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and 
FDA's implementing regulations, including whether an approved or cleared medical 
product is intended for a new use. This action w ill also repeal and replace the portions of 
a final rule issued on 9 January 2017, that never became effective. This action is intended 
to provide direction and clarity to regulated industry and other stakeholders.  
7. Objective and rationale, including th e nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety   
8. Relevant documents:  85 Federal Register (FR) 59718, 23 September 2020; Title 21 
Code of Federal Regulations (CFR) Parts 201 and 801:  
https://www.govinfo.gov/content/pkg/FR -2020-09-23/html/2020 -20437.htm  
https://www.govinfo.gov/content/pkg/FR -2020-09-23/pdf/2020 -20437.pdf  
This proposed rule and previous actions notified under the symbo l G/TBT/N/USA/1031  are 
identified by Docket Number FDA -2015-N-2002. The Docket Folder is available on 
Regulations.gov  at https://www.regulations.gov/docket?D=FDA -2015-N-2002 and G/TBT/N/USA/1031/Rev.1  
 
- 2 - 
 
  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 will be shared with the regulator and will also be submitted to the 
Docket  on Regulations.gov  if received within the comment period. Please note that late, 
untimely filed comments will not be considered.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be det ermined  
10. Final date for comments:  23 October 2020  
11. Texts available from:  National enquiry point [ ] or address, telephone or fax 
numbers  and email and website address es, if available , of other body:   
https://members.wto.org/crnattachments/2020/TBT/USA/20_5715_00_e.pdf