The US Food and Drug Administration (FDA) issued an updated final guidance on Tuesday addressing the submission of unique device identifiers (UDIs) to the Global Medical Device Nomenclature Database (GUDID).
This update features minor revisions from the previous guidance, including the removal of FDA Preferred Terms (FDA PT) or codes from the database, as they are no longer needed. The document updates a final guidance originally issued in June 2014.
The guidance update “reflects upcoming changes to the Global Medical Device Nomenclature (GMDN) field in GUDID and other minor clarifications. Since April 2019 the GMDN Agency allows access to GMDN Terms without a paid membership. Therefore, the option to use FDA Preferred Term (PT) Codes is no longer necessary and FDA intends to remove them from GUDID. Reference to the FDA PT codes is being removed from this guidance and GUDID users must use GMDN codes.”…
