Announcement of GUDID Release 2.2 Deployment and Document Updates


GUDID Release 2.2 was successfully deployed. The enhancements will allow for additional functionality as noted below.

  • Labelers will be able to “unlock” their device records after the DI record grace period to make error corrections. This will eliminate the need to contact the FDA UDI Help Desk to make corrections after the grace period.

Note that the Unlock functionality is intended to be used to correct data submission errors after the grace period. DO NOT USE Unlock functionality for edits that require assignment of a NEW Device Identifier. Please assign a new Device Identifier and submit a new record if you are changing data elements that are “New DI Triggers” (i.e., not correcting submission errors)

  • Addition of new data elements to the GUDID download file made available on AccessGUDID and OpenFDA to include –
  • Public Version Number
  • Public Version Date
  • Public Version Status (new/update/delete)
  • Public Device Record Key
  • Labeler DUNS Number
  • Premarket Submission Number & Supplement Number – note that this will be released after the testing/review period as indicated here.

GUDID documents (listed below) have been updated as of March 30, 2018.

We have also updated the GUDID System Enhancements and Fixes page to reflect all releases to-date.

If you have questions, concerns or feedback, please contact the FDA UDI Help Desk.


Related Resources

In September 2019, FDA announced its
Press Releases
CHICAGO, July 23, 2020 — In partnership with the Association for Health Care Resource & Materials Management (AHRMM) of the American Hospital A
The Unique Device Identifier (UDI) is comprised of 2 segments:
Karen Conway, Vice President, Healthcare Value at GHX and Mike Schiller, Senior Director of Supply Chain at AHRMM discuss the value of UDI beyond r
On-Demand Educational Webinars
The rapid advancement of barcode scanning and RFID technologies coupled with improved interoperability has enabled a new level of data analytics that…