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.

• GUDID Unlock User Manual – GUDID Unlock User Manual provides step-by-step instructions on how to unlock device records for editing after grace period.
• GUDID Data Elements Reference Table (March 30, 2018) – Please see the ‘ChangeLog’ sheet for details on the updates.
• GUDID HL7 SPL Implementation Files (March 27, 2018) – Please see the ‘ChangeLog’ sheet in the ‘ReadMeFirst.xls’ document for details on the updates.

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.