It was years in the making. But in September, the U.S. Food and Drug Administration issued a final rule on unique device identification or UDI, as well as a global database for all medical devices. As expected, the highest-risk (class III) medical devices will be first out of the chute. Many low-risk devices will be exempt from some or all of the requirements in the final rule. The final rule follows by 14 months the FDA’s proposed UDI rule. (See October 2013 Repertoire.)

 

The UDI system consists of two core items, according to the agency:

  • A unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label.
  • A publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID), which will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center, according to FDA.

 

Once fully implemented, the UDI system rule is expected to enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports, and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion, says FDA. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.

 

To view the FDA’s final rule on unique device identification, go to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

 

Look for more on this in Repertoire’s December issue.

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