The FDA announced a final rule for the unique device identification system (UDI) on September 20, 2013. “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 FDA worked closely with industry, the clinical community and patient and consumer groups in the development of the rule.
UDI System
The UDI system consists of two core items.
The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label.
The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center.
The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.
Recalls, Adverse Events and Electronic Records
The agency says the new system will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.
The FDA issued the proposed rule requesting input from industry, the clinical community and patient and consumer groups on July 10, 2012.
The UDI system builds on current device industry standards and processes, and reflects substantial input from the clinical community and the device industry during all phases of its development. In addition, the agency says it worked to reduce the burden on industry by building upon systems already in place. The system is a key component of the National Medical Device PostMarket Surveillance System proposed in September 2012.
In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act.
Comment on Submission Guidance
Included with the announcement was the publication of draft guidance for manufacturers outlining how to submit information to the database.
Click here to read the draft guidance.
If you have suggestions for the agency on the guidance, you have 60 days to comment.
