G/TBT/N/USA/1839/Add.1  
 
5 February 2024  
(24-0871) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  5 February 2024, is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title:  Medical Devices; Quality System Regulation Amendments  
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[ ] Notified measure adopted - date:  
[X] Notified measure published - date: 2 February 2024  
[X] Notified measure enters into force - date: 2 February 2026  
[X] Text of final measure available from1:  
89 Federal Register (FR) 7496, Title 21 Code of Federal Regulations (CFR) Parts 4 and 
820: 
https://www.govinfo.gov/content/pkg/FR -2024-02-02/html/2024 -01709.htm  
https://www.govinfo.gov/content/pkg/FR -2024-02-02/pdf/2024 -01709.pdf  
https://members.wto.org/crnattachments/202 4/TBT/USA/final_measure/24_01025_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[ ] Notified measure withdrawn or revoked - date:  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:  The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to 
amend the device current good manufacturing practice (CGMP) requirements of the Quality System 
(QS) regulation to harmonize and modernize the regulation. We are harmonizin g to align more 
closely with the international consensus standard for devices by converging with the quality 
management system (QMS) requirements used by other regulatory authorities from other 
jurisdictions (i.e., other countries). We are doing so by inco rporating by reference an international 
standard specific for device quality management systems. Through this rulemaking we also establish 
additional requirements and make conforming edits to clarify the device CGMP requirements for such 
 
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/1839/Add.1  
 
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  products. This act ion will continue our efforts to align our regulatory framework with that used by 
regulatory authorities in other jurisdictions to promote consistency in the regulation of devices and 
provide timelier introduction of safe, effective, high -quality devices f or patients.  
This rule is effective 2 February 2026. The incorporation by reference of certain material listed in 
this rule is approved by the Director of the Federal Register 2 February 2026.  
Title 21  Code of Federal Regulations (CFR) Parts 4 and 820 
This final rule and the proposed rule notified as G/TBT/N/USA/1839  are identified by Docket Number 
FDA-2021-N-0507. The Docket Folder is available from Regulations.gov at 
https://www.regulations.gov/docket/FDA -2021-N-0507/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.  
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