The Food and Drug Administration (FDA) has issued rule thatrequires medical device manufacturers to label their products with a uniquedevice identifier (UDI). Manufacturers are also required to submit theirproduct information to the FDA's Global Unique Device Identification Database(GUDID), pronounced 'Good id'.

The rule requires each medical device be marked with a UDIin both human readable and machine readable (AIDC - Barcode) formats.

The UDI will be required to be directly marked (DPM) on the device if it is to be used more than onceand reprocessed prior to re-use.