   
  
G/TBT/N/USA/1464  
 
10 April 2019  
(19-2314) 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 AME RICA  
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) [1496]  
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 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 [X], 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):  
Mammography quality; Quality (ICS 03.120), Radiation protection (ICS 13.280), Medical 
sciences and health care facilities in general (ICS 11.020), Medical equipment 
(ICS 11.040)  
5. Title, number of pages and language(s) of the notified document:  Mammography 
Quality Standards Act (18 page(s), in English)  
6. Description of content:  The Food and Drug Administration (FDA or Agency) is proposing 
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 proposing updates to modernize the regulations by incorporating 
current science and mammography best practices. These updates would improve the 
delivery of mammography services by strengthening the communication of healthca re 
information; allowing for more informed decision making by patients 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 improve mammography interpretations; modernizing 
technological aspects of the standards; and adding additional tools to deal with 
noncompliant facilities.  
7. Objective and rationale, including the nature of urgent pr oblems where 
applicable:  Protection of human health or safety; Quality requirements  
8. Relevant documents:   
• 84 Federal Register (FR) 11669, 28 March 2019; Title  21 Code of Federal 
Regulations (CFR) Part 900.  Will appear in the Federal Register when adopted.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  G/TBT/N/USA/1464  
 
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  10. Final date for comments:  26 June 2019  
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/2019/TBT/USA/19_2041_00_e.pdf  
 