Fda Unique Device Identification Udi Rule

While some parts of the rule became effective.

Fda unique device identification udi rule.

The labeler must submit product information concerning devices to fda s global unique device identification database gudid unless subject to an exception or alternative. Unique device identification udi the u s. Unique device identification system. 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.

Economic analysis of the final rule 2013 ref. The unique device identification system final rule udi rule requires device labelers typically the manufacturer to. On september 24 2013 fda published a final rule establishing a unique device identification system the udi rule. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier udi except where the rule provides for alternative.

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. This rule requires the label of medical devices to include a unique device identifier udi except where the rule provides for an exception or alternative placement.