FDA Issues Final Rule on Unique Device Identification System

October 4, 2013—The US Food and Drug Administration (FDA) announced the publication of its final rule on a system of unique device identifiers (UDIs) that, once implemented, will provide a consistent way to identify medical devices. The document can be downloaded from the FDA's website.

As summarized in the Federal Register on September 24, the FDA's final rule establishes a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a UDI, except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to the FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data-capture technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.

The FDA issued the proposed rule on July 10, 2012, requesting input from industry, the clinical community, and patient and consumer groups.

The FDA's website provides a section dedicated to the UDI system. Further, the FDA's regulatory impact analysis of the UDI system's final rule is available on its website.

The FDA advised that it has also published a draft guidance document for manufacturers outlining how to submit information to the database; that document is also available on the FDA's website.

According to the FDA, the UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the agency to identify product problems more quickly, better target recalls, and improve patient safety. The FDA noted that it has worked closely with industry, the clinical community, and patient and consumer groups in developing this rule.  

The agency advised that 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, which will 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 the GUDID publicly searchable database administered by the FDA 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.

The FDA stated that once fully implemented, the UDI system rule is expected to have many benefits for patients, the health care system, and the device industry. It 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, which will help address counterfeiting and diversion. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.   

In general, high-risk medical (class III) devices will be required to carry UDIs on their labels and packaging within 1 year, and this number and corresponding device information must be submitted to the new database. Manufacturers will have 3 years to act for most moderate-risk (class II) devices. Manufacturers of class I devices that are not exempt from UDI requirements will have 5 years to act.

Jeffrey Shuren, MD, JD, Director of the FDA's Center for Devices and Radiological Health, commented in the agency's press release, “UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation.”

Dr. Shuren added, “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.”

The agency noted that 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 FDA worked to reduce the burden on industry by building upon systems already in place. The UDI system is a key component of the National Medical Device Postmarket Surveillance System proposed in September 2012, the agency noted.