G/TBT/N/USA/720/Add.6  
 
26 July 2022  
(22-5620) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  26 July 2022, is being circulated at the request of the delegation 
of the United States of America . 
 
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Title:  Unique Device Identification System  
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[ ] Notified measure enters into force - date:  
[ ] Text of final measure available from1:  
[ ] Notified measure withdrawn or revoked - date:  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):   
[X] Interpretive guidance issued and text available from1:  
Availability of final guidance, which represents the current thinking of the Food and Drug 
Administration (FDA or Agency) on this topic. It does not establish any rights for any 
person and is not binding on FDA or the public. An alternative approach can be used if it 
satisfies the requirements of the applicable statutes and regulations.  
https://www.fda.gov/regulatory -information/search -fda-guidanc e-documents/unique -device -
identification -policy -regarding -compliance -dates -class-i-and-unclassified -devices  
https://www.govinfo.gov/content/pkg/FR -2022-07-25/html/2022 -15828.htm  
https://www.govinfo.gov/content/pkg/FR -2022-07-25/pdf/2022 -15828.pdf  
[ ] Other:  
https://members.wto.org/crnattachments/2022/TBT/USA/22_4932_00_e.pdf  
 
Description:  TITLE: Unique Device Identification: Policy Regarding Compliance Dates for Class I 
and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database 
Requirements for Certain Devices; Guidance for Industry and Food and Drug Administration Staff; 
Availability  
AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS)  
ACTION: Availability of guidance  
 
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/720/Add.6  
 
- 2 - 
 
  SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a 
final guidance entitled "Unique Device Identification: Policy Regar ding Compliance Dates for Class I 
and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database 
Requirements for Certain Devices." This guidance updates the previous version of the guidance, 
"Unique Device Identification: Polic y Regarding Compliance Dates for Class I and Unclassified 
Devices and Certain Devices Requiring Direct Marking," issued 1 July 2020. This final guidance 
explains FDA's compliance policy regarding Global Unique Device Identification Database (GUDID) 
submiss ion requirements for certain class I devices considered consumer health products and 
describes how a labeler of a class I devices can determine if its device is one of these devices. 
Additionally, the guidance explains that FDA intends to extend our existi ng compliance policy 
regarding GUDID submission requirements for class I and unclassified devices, other than 
implantable, life -supporting, or life - sustaining (I/LS/LS) devices, for an additional 75 calendar days. 
This guidance represents the current thin king of the FDA or Agency on this topic. It does not establish 
any rights for any person and is not binding on FDA or the public. An alternative approach can be 
used if it satisfies the requirements of the applicable statutes and regulations. To discuss an  
alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the 
title page.  
DATES: The announcement of the final guidance is published in the Federal Register on 25 July 
2022.  
This notice of availability of a final gui dance and a notice of availability of a draft guidance notified 
as G/TBT/N/USA/720/Add.5  are identified by Docket Number FDA -2017-D-6841. The Docket Folder 
is ava ilable from Regulations.gov at https://www.regulations.gov/docket/FDA -2017-D-
6841/document  and provides access to primary and supporting documents as well as comments 
received. Doc uments are also accessible from Regulations.gov  by searching the Docket Number. The 
Guidance Document is accessible from https://www.fda.gov/regulatory -information/search -fda-
guidance -documents/unique -device -identification -policy -regarding -compliance -dates -class-i-and-
unclassified -devices . Electronic or written comments on FDA guidance can be submitted at any time. 
WTO Members and their stakeholders are asked to submit comments on this guidance to the USA 
TBT Enquiry Point . Comments received b y 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.  
Previous actions notified under the symbol G/TBT/N/USA/720  are identified by Docket Number FDA -
2011-N-0090. The Docket Folder is available from Regulations.go v at 
https://www.regulations.gov/docket/FDA -2011-N-0090/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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