Form and content of the unique device identifier udi draft guidance for industry and food and drug administration staff 08 14 2016 gudid submission.
Fda unique device identification udi.
A unique device identification udi system is intended to provide single globally harmonized positive identification of medical devices through distribution and use requiring the label of devices to bear a globally unique device identifier to be conveyed by using automatic identification and data capture and if applicable its human.
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.
The global unique device identification database gudid is a database administered by the fda that will serve as a reference catalog for every device with a unique device identifier udi.
Form and content of the unique device identifier udi draft guidance for industry and food and drug administration staff pdf 384kb.
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.
Include a unique device identifier udi on device labels and packages.
The unique device identification system final rule udi rule requires device labelers typically the manufacturer to.
