GMDN Codes and GUDID

The Global Unique Device Identification Database (GUDID) requires the Global Medical Device Nomenclature (GMDN) PT Code. The final rule for Unique Device Identification (UDI) said that FDA-CDRH would allow a [user] who reports data to the GUDID to enter a GMDN code if the [user] knows it, or may use a module integrated in the GUDID reporting system to search for and select an appropriate GMDN term.

FDA-CDRH has developed a new GUDID module, Find FDA PT Codes, to enable users to select a FDA PT Code for GUDID submissions until a GMDN PT code can be obtained from the GMDN Agency. FDA PT Codes are a unique 4-letter code assigned to each GMDN PT Name, in place of the GMDN PT Code. The Find FDA PT Code module is enabled in GUDID Release 1.1 and can be accessed via the GUDID Web Interface by Coordinator and Labeler Data Entry (LDE) Users of GUDID. These FDA PT codes can also be submitted in HL7 SPL xml submissions.