UDI

The UDI is a common, worldwide system for product identification used to adequately identify devices through distribution and use.

The U.S. Food and Drug Administration (FDA) released a final rule in September 2013, which establishes that UDI should be applied to all medical devices placed on the U.S. market. The rule establishes that:

  • a unique device identifier number should be assigned by the device manufacturer to each version or model of a device
  • the unique device identifier should be both in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology

As part of the UDI system, the FDA also created the Global Unique Device Identification Database (GUDID), which includes a set of data attributes, for each device marked with a UDI. Manufacturers are responsible for submitting and maintaining their own data in the FDA's GUDID. The GUDID data is now available on OpenFDA, FDA’s portal for publicly available data. Making this data set available on OpenFDA allows public users to merge the GUDID device identification data with other FDA data sets. You will currently find an association from GUDID to FDA Classification data on OpenFDA, with plans to link to other FDA data sets in the future. The GUDID data set also continues to be available via search, download and APIs on AccessGUDID hosted by the National Library of Medicine (NLM).

Impact and Benefits of Proposed UDI Rule

Impact: The UDI rule in and of itself does not put any regulatory requirements on providers. However, providers are instrumental to a UDI system's success; if providers don't use the unique identifiers, much of the intended value of UDI will be lost.

Benefits: A unique medical device identifier will provide an important means for hospitals to better track medical devices for use in patient care, act in event of safety recalls, and manage their supply chains. UDIs also can be incorporated into electronic health records. 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 healthcare 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.