The FDA has extended by two years key requirements related to its new unique device identifiers (UDI)—a move that amounts to a tacit acknowledgement that adoption and implementation of that tracking system for medical devices is more challenging than originally anticipated, according to the Association for the Advancement of Medical Instrumentation (AAMI). The announcement came just weeks before an original end-of-month deadline in which Class II devices were to have labels that complied with the UDI requirements detailed in the agency’s final rule.
In a letter dated September 6, Thomas P. Gross, director of the Office of Surveillance and Biometrics in the FDA’s Center for Devices and Radiological Health, informed device labelers that the agency had extended the compliance date for requirements related to UDI labeling and entering information into the Global Unique Device Identification Database (GUDID) for certain Class II devices, specifically so-called “convenience kits” and repackaged single-use devices. That compliance date is now Sept. 24, 2018.
The rollout of the UDI system has had to be nuanced because of the complexity of medical devices. According to Zach Rothstein, associate vice president for technology and regulatory affairs at industry trade group AdvaMed, the FDA has done a “tremendous job” of answering questions and issuing additional guidance in the run-up to the approaching deadline.
“The FDA has been very proactive about providing extensions,” Rothstein says. “This is an opportunity for industry, FDA, and the entire ecosystem to coalescence around a standard or procedure that will work for these products.”
In his letter to industry, Gross wrote that postponing the deadline will give the agency more time to finalize its “interpretation of what constitutes a convenience kit,” as well as guidance on UDI compliance for these devices.
In draft guidance released earlier this year, the FDA stated that only those devices “packaged together for the convenience of the user where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user” would be exempted from UDI labeling requirements as long as a UDI was included on the label of the kit’s immediate container—a “change in policy” from the 2013 UDI rule.
The extension also applies to Class II single-use devices that are not individually labeled with a UDI. In addition, the FDA clarified that UDI requirements for device constituents of co-packaged and cross-labeled combination products assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research for premarket review would also come into effect in September 2018.
Implantable, life-sustaining, and life-supporting devices, as well as other Class II devices not listed in the letter, will still be required to display a UDI and have product information entered into GUDID starting September 24. This is the third step in phasing in the UDI system, a process scheduled to conclude in September 2020.
Visit AAMI’s Web site for more information regarding these changes.
Is the problem complexity or procrastination?