The UDI Rule and Kits

Labeling a medical device to comply with the UDI rule is enough of a challenge. What if the device is part of a kit – how do you uniquely label a medical product made up of multiple items? The rule states that if a device is packaged within the immediate container of a combination product or convenience kit, the label of that device will not be required to bear a UDI, provided that the label of the combination product or convenience kit bears a UDI.

To clarify this bit of the rule, it is useful to know how the FDA defines kits and combination products.

Convenience Kits are made up of legally marketed devices that can be sold independently, but can also be combined with other devices and sold together. Each item in the kit is already packaged and labeled for independent marketing, but is assembled in a kit for the convenience of the purchaser. An example of a convenience kit is a blood specimen collection kit. The FDA site has a complete list of convenience kits here.

Combination Products are made up of a drug and a medical device, a medical device and a biologic product, a biologic product and a drug, or a dug, device, and a biologic product. A common example of a combination product is an EpiPen®.

A combination product that already contains a National Drug Code (NDC) is exempt from the UDI, provided that each device in the combination product bears a UDI. The NDC is the unique identifier for human drugs in the United States.

Medical Procedure Kits consist of one or more medical devices, packaged together with one or more combination products, drugs, or biologics, to facilitate a single surgical or medical procedure. The medical procedure kit is typically packaged within a medical procedure tray so as to maintain sterility or to facilitate sterilization. The devices within a medical procedure kit are not necessarily individually packaged so that they can be used immediately upon opening the medical procedure kit. An example of this would be Orthopedic procedure kits.

In summary, only the convenience kit or combination product needs a UDI; components and constituent parts do not.