Publications
Unique Device Identification
“FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form.”
The publications below attempt to explain and distill the new UDI requirements and showcase the ThermaPrint64 label printer and applicator as a proven solution to implement the UDI system.
Guidelines for FDA Unique Device Identification Requirements
Label Printing to Meet 2013 FDA UDI Medical Devices Regulations