   
  
G/TBT/N/USA/1031/Rev.1/Add.1  
 
3 August 2021  
(21-6047) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  3 August 2021 , is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title: Regulations Regarding "Intended Uses"  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[X] Notified measure published - date: 2 August 2021  
[X] Notified measure enters into force - date: 1 September 2021  
[X] Text of final measure available from1:  
https://www.govinfo.gov/content/pkg/FR -2021-08-02/html/2021 -15980.htm  
https://www.govinfo.gov/content/pkg/FR -2021-08-02/pdf/2021 -15980.pdf  
https://members.wto.org/crnattachments/2021/TBT/USA/final_measure/21_5033_00_
e.pdf 
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:   
TITLE: Regulations Regarding "Intended Uses"  
AGENCY: Food and Drug Administration, HHS  
ACTION: Final rule  
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to 
amend its medical product "intended use" regulations. This final rule amends FDA's regulations 
describing the types of evidence relevant to determining whether a product is intended for use 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 a medical product that is 
approved, cleared, granted m arketing authorization, or exempted from premarket notification is 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/USA/1031/Rev.1/Add.1  
 
- 2 - 
 
  intended for a new use. This action also withdraws and replaces the portions of a final rule issued 
on 9 January 2017, that never became effective.  
This rule is effective 1 September 2021.  
This final rule and previous actions notified under the symbol 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/FDA -2015-N-2002/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.  
__________  
 
 