The FDA has been managing the Global Unique Device Identification Database (GUDID) to serve as a centralized reference of medical devices that have been assigned a Unique Device Identifier (UDI).

The database specifically includes only the Device Identifier (DI), which is the primary component of the UDI used to retrieve detailed device information. While Production Identifiers (PIs) are not directly stored in the GUDID, the system provides PI flags to indicate which PI elements, such as serial numbers or lot numbers, are included in the UDI for a particular device.

Meanwhile, on the recent update of FDA will be removing FDA Preferred Term (PT) Codes from the GUDID, as they are no longer needed. This change follows the recent decision to make GMDN Codes freely accessible to all users. 

The FDA will notify users once the changes to the GUDID are implemented. After the removal of PT Codes, users will be required to use GMDN Codes exclusively. To prepare for this transition, the FDA recommends that GUDID users begin switching from FDA PT Codes to GMDN Codes.

Resources are available on the https://www.gmdnagency.org/ webpage to help labelers identify appropriate GMDN Term Codes for their products including alternatives to obsolete term codes.
 

 

References:

Global Unique Device Identification Database (GUDID)

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