|Under the FDA's newly enacted UDI rule, devices must be shipped with a unique identification label. (Click to expand.)--Courtesy of the FDA|
After months of debate and delay, the FDA has imposed its final rule on unique device IDs (UDI), giving the makers of high-risk technologies a year to start labeling their products for tracking.
Under the UDI system, companies must assign each of their devices a one-of-a-kind number and barcode, all printed on a label that includes manufacturing and expiration dates. Each UDI will be registered with the FDA and cataloged in the soon-to-come Global Unique Device Identification Database, a publicly searchable resource with information on every tagged device, the agency said.
The final document includes a bevy of concessions the FDA made after more than a year of back and forth with the industry. Headlining those compromises is the agency's retraction of the proposed direct marking rule, which would have required manufacturers of implanted devices to stick UDI labels on the devices themselves.
The provision would have led to staggering costs of compliance for some companies, the industry argued, as many would need to re-demonstrate their implant's safety and effectiveness now that it carried a physical label. The FDA ditched the requirement for implants, allowing companies to put UDIs on packaging, but still mandates it for external devices.
Now that the system's in place, high-risk Class III devices, including pacemakers and vascular implants, must comply with the rule within one year, the FDA said. Most moderate-risk Class II devices will have three years to start labeling, and while many Class I devices are exempt from the UDI process, those that aren't get 5 years to act, according to the agency.
Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said the UDI system will benefit both agency and industry, allowing for better monitoring of devices, easier counterfeiting prevention and more effective research.
"A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used," Shuren said in a statement. "In turn, this can promote safe device use by providers and patients as well as faster, more innovative and less costly device development."
For its part, industry group AdvaMed applauded the FDA for addressing industry concerns in its final ruling. Beyond axing the direct marking rule for implants, the agency is now allowing multiple single-use devices within multi-packs to share a single UDI and has amended its compliance deadlines to let companies petition for more time.
AdvaMed is still poring over the final rule, Regulatory Affairs Vice President Janet Trunzo said, but the group believes the agency is on the right track.
"We are committed to working with FDA and other stakeholders to move forward in implementing this final rule to establish an effective UDI system that takes into account the diversity of medical devices and provides information useful to understanding their post-market performance," Trunzo said in a statement.
- read the final rule (PDF)
- check out the FDA's announcement
- here's AdvaMed's response