   
  
G/TBT/N/USA/1464/Add.2  
 
13 March 2023  
(23-1840) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  13 March 2023, is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title:  Mammography Quality Standards Act  
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[ ] Notified measure adopted - date:  
[X] Notified measure published - date: 10 March 2023  
[X] Notified measure enters into force - date: 10 September 2024  
[X] Text of final measure available from1:  
https://www.govinfo.gov/content/pkg/FR -2023-03-10/html/2023 -04550.htm  
https://www.govinfo.gov/content/pkg/FR -2023-03-10/pdf/2023 -04550.pdf  
https://members.wto.org/crnattachments/2023/TBT/USA/final_measure/23_1875_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[ ] Notified measure withdrawn or revoked - date:  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: Mammography Quality Standards Act AGENCY: Food and Drug Administration, 
HHS 
ACTION: Final rule  
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to update 
the mammography regulations that were issued under the Mammography Quality Standards Act of 
1992 (MQSA)  and the Federal Food, Drug, and Cosmetic Act (FD&C Act) . We are issuing updates t o 
modernize the regulations by incorporating current science and mammography best practices. These 
updates are intended to improve the delivery of mammography services by strengthening the 
communication of healthcare information; allowing for more informed  decision making by patients 
 
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/1464/Add.2  
 
- 2 - 
 
  and providers (by requiring facilities to provide them with additional health information); helping to 
ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit 
to provide feedback to imp rove mammography interpretations; modernizing technological aspects 
of the standards; and adding additional tools to deal with noncompliant facilities.  
DATES: This rule is effective on 10 September 2024.  
This final rule and previous actions notified under the symbol G/TBT/N/USA/1464  are identified by 
FDA-2013-N-0134. The Docket Folder is available from Regulations.gov at 
https://www.regulations.gov/docket/FDA -2013-N-0134/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.  
__________  
 
 