The U.S. Food and Drug Administration (FDA) has published an updated guidance to assist medical device manufacturers in preparing unique device identification (UDI) information for inclusion in the agency’s Global Unique Device Identification Database (GUDID).
Published in mid-December, the updated version of the Guidance, “Global Unique Device Identification Database (GUDID),” provides device manufacturers with the FDA’s recommendations on the information that should be supplied to ensure that device-specific data is successfully posted on the GUDID. Specifically, the updated guidance replaces an earlier version issued in 2014, adopting the information profile reflected in the Global Medical Device Nomenclature (GMDN) and replacing the previously used FDA Preferred Terms (FDA PT) Codes.
The FDA’s UDI requirements create a standardized identification system for medical devices and for stand-alone software that is regulated as a medical device. UDI systems make it possible to definitively identify a medical device quickly, and to verify its key attributes to help ensure its safe and effective use.
Guidance documents issued by the FDA and other federal agencies are intended solely to provide interested parties with information on the current views of the agency with regard to a specific issue and do not have the force of law.
The FDA’s updated GUDID guidance is available at https://www.fda.gov/media/86569/download.
