FDA Proposes Rule on Unique Device Identification (UDI) for Medical Devices

In July 2012, the U.S. FDA announced its proposed regulatory language for a Unique Device Identification (UDI) system for most medical devices distributed in the United States. Based on legislation passed in September 2007, this proposal would establish a unique and uniform labeling system to identify U.S. medical devices throughout the supply chain, from manufacturer to provider.
The proposed UDI system has the potential to improve the quality of information on medical devices, including adverse events reports. This information helps the FDA identify product problems more quickly, better target recalls, and improve patient safety.
In addition to existing label requirements for medical devices, a UDI compliant label would include a device identifier, which is specific to the model of the medical device, and a production identifier, which includes the device’s recent production information, such as the lot or batch number and the serial number. This information would be displayed on the device as both human readable data and machine readable information.  Typically this means the item would be encoded in linear or 2D bar codes. The information about the item will be contained in a publicly available UDI database. No patient identification information will be held in the database.
Expected benefits of Unique Device Identification include:

• Creating a uniform identifier that allows manufacturers, distributors and healthcare facilities to effectively manage medical device recalls.
• Providing a foundation for a global, secure supply chain, which addresses counterfeiting and preparations for medical emergencies.
• Reducing medical errors by enabling health care professionals to more quickly and accurately identify a device and its characteristics.
• Generating more accurate information and analysis of adverse event reports to quickly identify and correct problem devices.
• Developing a medical device identification system that is recognized around the world.

The FDA’s proposed rule on UDI is currently in the comment phase, with implementation projected for late 2013. Camcode will continue to research, review, and understand the information provided on the UDI initiative, and offer our thoughts and comments as new developments occur.
For more information on the FDA’s proposed rule on Unique Device Identification for medical devices, visit:
FDA.gov
OpenCongress.org
Regulations.gov 
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