Glossary and Definitions

Results: 56

Unique Device Identifier (UDI)

The FDA has released a final rule that establishes the Unique Device Identification (UDI) system for medical devices as a result of the Food and Drug Administration Amendments Act (FDAAA) of 2007. The new system will require the label of a device to have a Unique Device Identifier, unless otherwise specified by the U.S. FDA or given other exceptions.… Learn more →