[This post is part of a two part series on the FDA's final rule on UDI. You can find Part 2 here.]
FDA Final Rule
In an important release dated September 20, the Federal Drug Administration (FDA) announced its final rule for the unique device identification (UDI) system designed to provide a consistent way to identify medical devices.
The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community, and patient and consumer groups in the development of this rule.
“UDI represents a landmark step in improving patient safety, modernizing our post-market 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 system consists of two core items:
- 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.
- 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.
Phasing in UDI
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. 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, 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.
“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 UDI system builds on current device industry standards and processes, and reflects substantial input from the clinical community and the device industry that was received during all phases of development. In addition, the FDA worked to reduce the burden on industry by building on systems already in place. The UDI system is a key component of the National Medical Device Post Market Surveillance System proposed in September.
Timeline for UDI Implementation
>In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year; 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.
What about you?
Are you feeling the weight of the UDI final rule? Let us know in the comments what kind of challenges you expect in implementing UDI requirements.