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Unique Device Identification

Safety and effectiveness of medical devices

In 2013, the Food and Drug Administration (FDA) released a final rule establishing a unique device identification  (UDI) system designed to adequately identify devices through distribution and use.   UDI will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation. The final rule requires device labelers to include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology.  The  UDI on the label of devices will be in human and machine-readable form.The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use. Dates on device labels and packages are to be presented in a standard format that is consistent with international standards and international practice.

All UDIs are to be issued under a system operated by an FDA-accredited issuing agency opens in a new tab.  The UDI system will go into effect in stages opens in a new tab, over a period of seven years, to ensure a smooth implementation and to spread the costs and burdens of implementation over time, rather than having to be absorbed all at once.

The Global Unique Device Identification Database (GUDID) opens in a new tab is a database administered by the FDA that will serve as a reference catalog for every device with a unique device identifier (UDI). GUDID contains ONLY the device identifier (DI) portion of the UDI, which serves as the key to obtain device information in the database.