Fda Unique Device Identification Udi

Unique device identification system.

Fda unique device identification udi.

Unique device identification system. Include a unique device identifier udi on device labels and packages. Food and drug administration fda created unique device identification often abbreviated udi a rule that requires medical device manufacturers to update their products with a unique device identifier that includes both device and production identifiers such as expiration date and lot or serial number. Include a unique device identifier udi issued under an fda accredited issuing agency s udi system on device labels device packages and in some instances directly on the device.

A class ii device that is required to be labeled with a udi must bear a udi as a permanent marking on the device itself if the device is a device. Form and content of the unique device identifier udi draft guidance for industry and food and drug administration staff 08 14 2016 gudid submission. Form and content of the unique device identifier udi draft guidance for industry and food and drug administration staff pdf 384kb. The unique device identification system final rule udi rule requires device labelers typically the manufacturer to.