G/TBT/N/USA/1839  
24 February 2022  
(22-1777) 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 AMERICA   
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) [1868]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the not ification 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):  Medical 
devices; Quality (ICS 03.120), Medical equipment (ICS 11.040)  
5. Title, number of pages and language(s) of the notified document:  Medical Devices; 
Quality System Regulation Amendments (16 page(s), in English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA, the 
Agency, or we) is proposing to amend the device current good manufacturing practice 
(CGMP) requirements of the Quality System (QS) Regulation 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 propose to do so through incorporating by 
reference an  international standard specific  for device quality management systems  set 
by the International Organization for Standardization (ISO), the 2016 edition of ISO 
13485 (ISO 13485). Through this rulemaking we also  propose additional requirements to 
align with existing requirements in  the Fe deral Food, Drug, and Cosmetic Act (FD&C Act) 
and its  implementing regulations, and make conforming edits to the Code of  Federal 
Regulations (CFR) to clarify the device CGMP requirements for  combination products. This 
action, if finalized, will continue ou r efforts to align our regulatory framework with that 
used by other  regulatory authorities to promote consistency in the regulation of  devices 
and provide timelier introduction of safe, effective, high -quality devices for patients.  
7. Objective and ration ale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Quality requirements; Harmonization; 
Reducing trade barriers and facilitating trade  
8. Relevant documents:   
87 Federal Register (FR) 10119, 23 February 2022; Title  21 Code of Federal Regulations 
(CFR) Parts 4 and 820:  G/TBT/N/USA/1839  
 
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  https://www.govinfo.gov/content/pkg/FR -2022-02-23/html/2022 -03227.htm  
https://www.govinfo.gov/content/pkg/FR -2022-02-23/pdf/2022 -03227.pdf  
This proposed rule is 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 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  by or before  4pm Eastern Time  on 24 May 2022.  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.   
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  24 May 2022  
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/2022/TBT/USA/22_1776_00_e.pdf