FDA Finalizes UDI Guidance

In mid-November the FDA finalized their guidance for establishing a unique device identification (UDI) system to identify medical devices through their distribution and use. A draft guidance was released for review in 2015. The FDA has said that responses they received during the review process will be considered for subsequent revisions.

The UDI markings are required when a device is intended to be used more than once and reprocessed before each use. The guidance clarifies when direct marking of a device is required by defining the FDA’s interpretation of “used more than once” and “reprocessed.” Additionally, the guidance clarifies criteria for exceptions to the direct marking requirements. Recommendations for how labelers should comply with the direct marking requirements are also included.

For more information on UDI requirements check out the FDA’s Unique Device Identification.