FDA Releases Final Unique Device Identification Rule

FDA has finalized its Unique Device Identification (UDI) regulation intended to drive consistency in medical device identification. The final rule requires that most medical devices distributed in the United States bear a unique device identifier, the agency posted on its UDI page today. The initiative also entails listing all devices with identifiers in a publicly searchable database administered by FDA, called the Global Unique Device Identification Database (GUDID).

"UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in a statement issued by FDA.

FDA had published its UDI proposed rule on July 10, 2012.

Jay Crowley, FDA's Senior Advisor for Patient Safety, Center for Devices and Radiological Health, spoke about the final rule today at the UDI Conference in Baltimore.

According to FDA, the unique device identifier is made up of a device identifier (DI) and a production identifier (PI), which is detailed as follows:

  • The DI is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
  • The PI is a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:  
    * The lot or batch number within which a device was manufactured;
    * The serial number of a specific device;
    * The expiration date of a specific device;
    * The date a specific device was manufactured
    * The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

Click on these links for more information on the Unique Device Identification final rule as well as Draft Guidance for Industry on the Global Unique Device Identification Database (GUDID).

On September 26 PMP News will be hosting a Webcast featuring AIM North America's subcommittee on FDA’s UDI rule. Speakers will offer recommendations for standards addressing interoperability and business models. The Webcast will feature Ron Ducharme, Product Manager, FLEXcon; Clive Hohberger of The BloodCenter of Wisconsin, and John Schneider, Innovation & Business Development Director, ITW Foils & Thermal Films. To register for the free event, which is sponsored by FLEXcon, click here. 

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