GUDID Update – Premarket Submission Supplement Number

OMEDtechNews & Events

GUDID Enhancements

The GUDID system will soon undergo enhancements.  These improvements will allow the system to continue meeting user and program needs. The GUDID Release 2.3 will include the public release of the Premarket Submission Number and the Supplement Number which will become part of each GUDID DI record.

Before the GUDID enhancements are implemented, the FDA suggests that users review their GUDID listings and prepare for how they may be impacted by the changes. In May 2018, the FDA plans to update GUDID so that labelers will have the opportunity to review the premarket submission number and to identify the releasability of a premarket submission number and supplement number for their GUDID listings. Premarket numbers may be kept confidential depending on their confidentiality designation.

How to Prepare

Users can review and make changes to any confidentiality designations on the Device Registration and Listing Module (DRLM). It is important to prepare for the changes by checking your GUDID records and confirming they have all relevant listing numbers and to review and/or change the confidentiality designations. The public release of premarket submission and supplement numbers will occur in June 2018.