US FDA Revisits UDI Requirements for “Convenience Kits”
US medical device regulators have revised how they define “convenience kits”—two or more medical devices packaged together—in terms of Unique Device Identification (UDI) requirements.
The Food and Drug Administration draft guidance defines a convenience kit as two or more devices sold in a single package for convenience; no additional processing or modification of the devices may occur before their use by patients or users. For qualifying convenience kits, only package labels must show UDI numbers, not the devices contained in those packages.
In the context of UDI compliance, it is important to note how the FDA has altered how it defines convenience kits. Initially, the regulator had considered medical procedure kits such as orthopedic procedure kits, from which some devices were used for medical procedures while others were re-sterilized and repackaged, as convenience kits and thus exempt from individual device UDI labeling rules. The new guidance limits the definition of convenience kits to exclude any devices that may go through further processing once packaging is opened by the end user.
The guidance also provides examples of medical device kits that do qualify as convenience kits—first aid kits, anterior cruciate ligament (ACL) disposable kits—and those that do not qualify as convenience kits—non-sterile orthopedic device trays, reusable devices packaged together.
Manufacturers whose products had previously qualified as convenience kits may need to reassess whether the new guidance changes those qualifications, and adjust their UDI compliance processes if necessary.