UDI final rule finally issued

More than a year after the proposed rule was issued, the FDA released the final rule establishing a unique device identification (UDI) system for tracking medical devices.

There are two main components of the UDI system created under FDA's final rule. The first is a unique identifier assigned by manufacturers to track devices' lot or batch number, expiration date and manufacturing date. The second component is a public, searchable database administered by FDA—called the Global Unique Device Identification Database—that will serve as a reference catalogue for all devices that have an identifier.

The FDA received 270 comments from 225 entities, including manufacturers, consumer groups, doctors and hospitals.

The final rule aims to:

• Enable quick and efficient recall of medical devices;
• Improve the accuracy and specificity of adverse event reports;
• Provide a secure, global distribution chain to address counterfeiting and diversion; and
• Offer a clear path for documenting device use in EHR systems and clinical information systems.

The rule also creates accreditation requirements for agencies that will issue UDI codes.

The final rule will take effect in about 90 days and will be implemented in phases over seven years at the cost of $86 million annually. Most high-risk medical devices will be required to carry a UDI on their label within the next year, while moderate-risk devices will have three years to implement UDIs. Many low-risk devices will have five years to implement UDIs or will be exempt from the rule's requirements altogether.