
The FDA’s final guidance in 2013 explains the UDI purpose and requirements. A UDI must be included on most device labels and packages, and device identification information must be submitted to the FDA’s Global Unique Device Identification Database (GUDID).
The UDI system is being implemented over several years, beginning with the highest risk medical devices and continuing until the records of all medical devices required to have a UDI are included. Through AccessGUDID, the public can search device identification and important safety information that labelers have submitted about their medical devices to the GUDID.
For more information about UDI, GUDID, and AccessGUDID, or to view UDI training modules, visit the FDA’s UDI webpage.