The UDI must be issued under a system operated by an FDA-accredited issuing agency. The issuing agency does not necessarily create each UDI, rather the issuing agency will assign a unique company identifier and provide guidance on the creation and maintenance of UDIs. While the issuing agency will have its own guidelines, it is critical that the UDI also conform to the requirements listed under the UDI Rule.
To publish a device record to AccessGUDID, you need to submit your record to the FDA Global UDI Database (GUDID). Please see the FDA’s website for information on how to prepare to submit device records to GUDID.