FDA: New system to identify medical devices finalized

The FDA plans to phase in the new UDI system, first focusing on high risk medical devices.

The U.S. Food and Drug Administration has announced a final rule for the unique device identification system (UDI) that will provide a consistent way to identify medical devices, once implemented. The UDI system can potentially improve the information quality of adverse events reports in medical devices and will help the FDA in identifying problems more quickly, target recalls better and improve patient safety. The FDA worked closely with industry, the clinical community and patient groups to develop these rules.

“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.

The UDI systems has two core items: a unique number assigned by the device manufacturer to the version or model of a device and a publicly searchable database administered by the FDA that will be a reference catalogue for all devices with an identifier. No identifying patient information will be stored in the database, however.

The FDA plans to phase in the new UDI system, first focusing on high risk medical devices. A lot of low risk devices will be exempt from all, or at least some of the requirements in the final rules.

Once fully implemented, the UDI system rule is expected to provide many benefits to patients, the health care system and the device industry. It will enhance the ability to identify marketed devices during recalls, improve the accuracy and specificity of adverse event reports and provide the foundation for a global, secure distribution chain that will help address counterfeiting and diversion. Additionally, it will provide a clear way of documenting use of devices in electronic health records and clinical information systems.

“A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development,” said Shuren.

The FDA issued the proposed rule and requested input from industry, the clinical community and patient and consumer groups on July 10, 2012. The UDI system is a key component of the National Medical Device PostMarket Surveillance System proposed in September 2012.

High risk medical devices (Class III) will be required to carry a unique device indentifier on their label and packaging within a year. The number and corresponding device information must also be submitted to the new database. Manufacturers are being given three years to act for most moderate risk devices (Class II). Manufacturers of low risk devices (Class I) that are not exempt from the UDI requirements will have five years to act.