GUDID Document Updates Now Available

The following GUDID documents have been updated:

• GUDID Data Elements Reference Table - April 14, 2016 -- updates made based on user feedback. See the ‘ChangeLog’ tab at bottom of the document for details on the updates.
• GUDID HL7 SPL Implementation Package - April 14, 2016 -- updates include addition of C-code to submit De novo premarket submission type and changes to improve clarity of the information based on user feedback. Please see the ‘ChangeLog’ tab at the bottom of the ‘ReadMeFirst.xls’ document for complete details.

Additionally, the GUDID System Enhancements and Fixes page has been updated to reflect all releases to-date.

For all questions on UDI and GUDID, please contact the FDA UDI Help Desk.

Thank you.

Sincerely,

FDA UDI Team