Preparing Data for GUDID
Prior to beginning the GUDID process, device labelers often take actions related to organizing, collecting and validating data. Labelers may house necessary information in multiple systems and locations, making internal system coordination a key aspect of preparing data for GUDID.
Checklist: Steps to Prepare for GUDID
To help streamline the GUDID submission process and efficiently meet UDI requirements, complete each of these steps before requesting a GUDID account:
- 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 (June 27, 2019).
- Understand the GUDID account structure and user roles as shown in the GUDID Guidance (see figure 1 on page 8).
- Understand the GUDID user roles and responsibilities
- Identify individuals for the GUDID user roles
- Identify/obtain appropriate Dun and Bradstreet (DUNS) numbers
- If your company has the appropriate DUNS number(s), verify that the information in the D&B database is correct and update any information if necessary. For information on the DUNS number, refer to Section 3.1.1 of the GUDID Guidance.
- If your company does not have one or more DUNS numbers, 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. Two options are available, and you may use one or both options to submit your data:
- Manual Data Entry via GUDID Web Application: For submitting DI records online. This is the best option for companies with small quantities of records.
- HL7 SPL File Submission via FDA Electronic Submissions Gateway: For submitting DI records in XML files that comply with Health Level 7 (HL7) Structured Product Labeling (SPL). This option allows companies with large quantities of records to submit multiple records simultaneously.
IMPORTANT: To use this option, you must establish an FDA Electronic Submissions Gateway 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.