Medical Devices

Prepare for GUDID

FDA’s experience and feedback from industry indicate that device labelers often take a number of actions related to organizing, collecting and validating data --- before they get a GUDID account or submit device identifier (DI) records. Importantly, labelers may house necessary information in multiple systems and locations, making internal system coordination a key aspect of preparing data for the GUDID. We strongly encourage labelers to take the following steps to ensure their readiness to meet UDI requirements and streamline the GUDID submission process:

  • Review UDI guidance documents and resources to create an internal action plan/timetable for preparing data for the GUDID.
  • Work with FDA-accredited issuing agencies to assign and maintain UDIs. Establish processes for physical labeling.
  • Establish standard operating procedures for records management.
  • Gather data required for GUDID DI records based on the GUDID Data Elements Reference Table.
  • Understand the GUDID account structure and user roles as shown in the GUDID Guidance (see figure 1).
    • Identify individuals for the GUDID user roles and ensure that they understand GUDID functionality and responsibility for their user roles
  • Identify/obtain appropriate Dun and Bradstreet (DUNS) numbers
    • If your company has a DUNS number(s), verify that the information in the D&B database is correct and update any information if necessary.
    • If your company does not have a DUNS number(s), you can obtain one free of charge from D&B. Please note that this may take up to 30 business days; please plan accordingly.
    • Expedited options to obtain a DUNS number are available for a nominal fee.
  • Determine a GUDID submission option (GUDID Web Interface vs. HL7 SPL submission).
    • If choosing HL7 SPL submission, establish a FDA ESG account and complete required testing.
  • If needed, select a third-party submitter. For information on third-party submission, please refer to the GUDID Guidance.
  • Subscribe to the UDI mailing list to be notified about updates for the UDI program.
  • Subscribe to the GUDID mailing list to be alerted to database changes and GUDID system status updates.

Page Last Updated: 01/15/2015
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