Updates to the GUDID final Guidance

GUDID guidance is intended for device labelers and provides essential information for submitting data to the Global Unique Device Identification Database (GUDID). Below highlighted are the key update…

• Changes to the Global Medical Device Nomenclature (GMDN) field
• Enhanced user experience features, and responsibilities for maintaining accurate device identifier (DI) records.

This comprehensive framework ensures that device labelers have the necessary resources to navigate and comply with GUDID requirements effectively.

Overview of Key Changes

Updates to GMDN Code Requirements and Removal of FDA Preferred Term (PT) Codes

Since April 2019, the GMDN Agency has allowed access to GMDN code without requiring a paid membership. As a result, the option to use FDA PT Codes is no longer necessary, and the FDA intends to remove these codes from the GUDID.

References to FDA PT codes are being removed from the guidance. Going forward, GUDID users must use GMDN codes.

New Section on Maintaining GMDN Codes in DI Records

Labelers are responsible for maintaining accurate and up-to-date DI record information throughout the device’s Total Product Lifecycle (TPLC).

For GMDN Members: Notifications will be provided when terms are modified or become obsolete.

For Non-Members: Labelers are responsible for monitoring their GMDN terms periodically or when required by validation rules.

If a GMDN Term becomes obsolete, the labeler or LDE user must update the GMDN Term to ensure successful validation when modifying any other DI record attribute.

Once a DI record is published in the GUDID with an active GMDN Term, that assignment remains unchanged unless updated by the labeler or LDE user. The GUDID does not automatically update GMDN terms.

Updates to GMDN information must be submitted within 10 business days of any change

Enhancements to User Experience

Database improvements aim to streamline the user experience through better validation rules and user interface enhancements. Feedback will continue to shape system updates, with periodic revisions to the guidance reflecting these changes.

Specific Considerations for HCT/P Labelers

Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) are required to assign and label each HCT/P with a distinct identification code. This code must enable manufacturers to relate the HCT/P to the donor and all associated records. The distinct identification code may include:

• Donation identification number
• Serial number
• Lot number
• A combination of these production identifiers

HCT/P labelers regulated as medical devices should ensure they select the appropriate type of production identifier that matches the device label in the GUDID.

Conclusion

The updated guidance serves as a critical resource for device labelers, outlining the importance of maintaining accurate and up-to-date DI records throughout a device’s lifecycle. By transitioning fully to GMDN codes, eliminating outdated FDA PT Codes, and implementing enhanced database features, the GUDID ensures a streamlined and compliant framework for device identification. These updates support better data accuracy, user experience, and regulatory adherence.