Unique Device Identification

The Food and Drug Administration (FDA) has released a proposed rule that most medical devices distributed in the United States carry a unique device identifier, or UDI. Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices.

A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety.

A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.

The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to the public so that users of a medical device can easily look up information about the device. The UDI does not indicate and FDA’s database will not contain any information about who uses a device, including personal privacy information.

In developing the proposed rule, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies.

Read the Unique Device Identifier Proposed Rule here.

Benefits of Unique Device Identification

When fully implemented, the UDI system may:

• Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
• Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
• Enhance our analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust postmarket surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
• Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
• Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
• Lead to the development of a medical device identification system that is recognized around the world.
   

Contact Us

For further information contact:
Jay Crowley
Center for Devices and Radiological Health
Food and Drug Administration
Phone: 301-796-5995
e-mail: Jay.Crowley@fda.hhs.gov