Medical device manufacturers have a choice of standards to use when identifying their products for the U.S. market. The FDA’s Unique Device Identification (UDI) rule allows them to select from any identification standards organization (referred to as a “number issuing” agency) that is accredited by the Agency for that purpose. So far, three organizations have been FDA-accredited: HIBCC, ICCBBA and GS1.
ICCBBA has a lock on the identification of Continue reading GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care