G/TBT/N/USA/720/Add.5  
 
15 October 2021  
(21-7839) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION  
Addendum  
The following communication , dated  15 October 2021 , is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
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[  ] Notified measure withdrawn or revoked - date:  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:  
https://www.govinfo.gov/ content/pkg/FR -2021-10-14/html/2021 -22308.htm  
https://www.govinfo.gov/content/pkg/FR -2021-10-14/pdf/2021 -22308.pdf  
https://members.wto.org/crnattachments/2021/TBT/USA/interpretative_guidance/21_
6569_00_e.pdf  
The "2020 UDI Compliance Policy Guidance," is available at: 
https://www.fda.gov/regulatory -information/search -fda-guidance -documents/select -
updates -unique -device -identification -policy-regarding -global -unique -device -
identification . This draft guidance is not final nor is it in effect at this time. This guidance 
is being distributed for comment purposes only.  
[  ] Other:  
 
Description:  Select Updates for Unique Device Identification: Policy Regarding Global Unique Device 
Identification Database Requirements for Certain Devices; Draft Guidance for Industry and Food and 
Drug Administration Staff; Availability  
AGENCY: Food and Drug Administration, HHS.  
ACTION: Notice of availability.  
 
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.5  
 
- 2 - 
 
  SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability 
of the draft guidance entitled "Select Updates for Unique Device Identification: Policy Regarding 
Global Uniq ue Device Identification Database Requirements for Certain Devices; Draft Guidance for 
Industry and Food and Drug Administration Staff." This draft guidance explains that there are certain 
class I devices for which FDA does not intend to enforce Global Uni que Device Identification Database 
(GUDID) submission requirements and describes how a labeler of a class I device can determine if 
its device is one of these devices in the revised section III of this draft guidance. When this draft 
guidance is finalized,  the updates in section III of this draft guidance would supersede the 
recommendations in section III of the guidance "Unique Device Identification: Policy Regarding 
Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct  Marking" 
("2020 UDI Compliance Policy Guidance," available at: https://www.fda.gov/regulatory -
information/search -fda-guidance -documents/select -updates -unique -device -identification -policy -
regarding -global -unique -device -identification ). This draft guidance is not final nor is it in effect at 
this time.  
DATES: Subm it either electronic or written comments on the draft guidance by 13 December 2021 
to ensure that the Agency considers your comment on this draft guidance before it begins work on 
the final version of the guidance.  
This notice of availability is identified  by Docket Number FDA -2017-D-6841. The Docket Folder is 
available on Regulations.gov  at https://www.regulations.gov/dock et/FDA -2017-D-6841 and provide 
access to documents associated with the notice. Documents are also accessible from Regulations.gov  
by searching the Docket Number. We note this is a "Nonrulemaking Dock et".  
WTO Members and their stakeholders are asked to submit comments on the draft guidance  to the 
USA TBT Enquiry Point . Comments received by the USA TBT Enquiry Point from WTO Members and 
their stakeholders will b e shared with the FDA and will also be submitted to the Docket  on 
Regulations.gov  if received within the comment period.  
Previous rulemaking and related actions notified under the symbol G/TBT/N/USA/720  ("Unique 
Device Identification System") are identified by Docket Number FDA -2011-N-0090. The Docket 
Folder for the rulemaking is availabl e on Regulations.gov  at 
https://www.regulations.gov/docket/FDA -2011-N-0090/document  and provides access to primary 
and supp orting documents as well as comments received. Documents are also accessible from 
Regulations.gov  by searching the Docket Number.  
__________