UDI Accredited Agencies

FDA-CDRH recently increased the list of accredited agencies for UDI. There are 3 accredited agencies: GS1, Health Industry Business Communications Council (HIBCC), and ICCBBA.

Medical device manufacturers must use an accredited agency to issue a UDI and populate the GUDID. To learn the details of these accredited organizations, go to the FDA-CDRH website at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm