Following pressure from distributors, the Food and Drug Administration announced Wednesday that it would extend a deadline for firms to comply with new labeling guidelines for prepackaged kits and repackaged single-use devices.
As a part of the rollout of the FDA's new unique device identifier system, class II devices – the intermediate risk devices in the FDA's three-class system – will be required to have a UDI marked on their labels and packaging, and data on the device must be submitted to an FDA database, as of September 24th of this year. Distributors had asked the agency to clarify how those rules applied to repackaged single-use class II devices and so-called “convenience kits” that contain two or more class II devices, both of which now have until Sept. 24, 2018 to comply with the UDI rule.
The two-year extension applies to kits that contain two or more class II devices that aren't otherwise labeled individually and applies to all repackaged class II devices except implants. The extra time will allow the FDA to finalize draft guidance issued in January that defines convenience kits in relation to the UDI rule, the agency said in a letter Wednesday.
Distributors like Cardinal Health, Henry Schein and Owens & Minor are often responsible for placing devices into kits intended for specific procedures, or repackaging them for smaller orders. Their industry lobby, the Health Industry Distributors Association, had pushed for clarification on how UDI requirements apply to these products.
In an interview earlier this year, Linda Rouse O'Neill, HIDA's vice president, told Modern Healthcare that distributors still had questions over whether, for example, each syringe in a box of individually wrapped syringes needs to be labeled with a UDI, considering that the syringes will likely be going to different locations in a provider facility. “FDA has been has been super helpful in those conversations and trying to figure out,” she said at the time.
“This announcement allows the government to achieve its goal of full UDI implementation while recognizing the complexities of the supply chain,” said HIDA President & CEO Matthew Rowan, in a statement. “The extension provides necessary time to develop industry best practices around repackaged single-use devices, and allows convenience kit compliance to align with Class I deadlines," which are scheduled to go into effect in 2018.
The FDA also issued a two-year extension for certain combination products that aren't implantable, life-saving or life-supporting, like a drug- or biologic- emitting device, a biologic that also includes a drug or a combination of all three. The extension does not apply to other class II devices, and it doesn't apply to kits that contain one or more devices that are implantable, life-sustaining or life-supporting, for which UDI requirements are already in effect for the individual products.