FDA finalized guidance seeking to clarify its definition of convenience kits for unique device identifier (UDI) labeling. The convenience kit guidance has been of particular interest to orthopedic manufacturers, as they sought direction on UDI placement.
FDA offers the following definitions and descriptions as references for UDI requirements:
- Convenience kit: A convenience kit is “two or more different medical devices packaged together for the convenience of the user” (21 CFR 801.3). FDA interprets this to mean a device that contains two or more different medical devices packaged together and intended to remain packaged together and not to be replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user.
- Packaged together: Packaged together means packed (e.g., wrapped or sealed) in a single container that is not intended to be unwrapped or unsealed before it is used by an end user.
- Medical procedure kit: A medical procedure kit typically consists of one or more medical devices, packaged together to facilitate a single surgical or medical procedure. A medical procedure kit may be a convenience kit, but not all medical procedure kits qualify as a convenience kit.
In its guidance, FDA acknowledged that the interpretation of these terms may reduce the number of medical procedure kit exceptions and that this may disrupt some assembly and packaging of materials. Nevertheless, FDA believes its interpretation of the term “convenience kit” to be appropriate, and manufacturers should make adjustments as necessary.
The guidance also confirms that individual devices packaged within the container of a convenience kit do not need UDIs, provided that a UDI is on the label of the convenience kit container.
Within FDA’s new guidance are several orthopedic examples of ways that combined products may or may not be considered convenience kits, moving forward. In one example, a collection of orthopedic devices comprising implants and reusable instruments are removed from packaging and placed into a sterilization tray for cleaning and sterilization. However, only a few of the products in each set are selected for implantation in a single procedure on a single patient, and the sets are later replenished with different implants. This is not considered to be a convenience kit because the devices are not sealed, sterile and intended to remain packaged together before utilization by an end user.
Another example is a single use, disposable medical procedure kit, such as an anterior cruciate ligament procedure kit. In this situation, the kit includes devices that are packaged and sealed in a single sterile container. The container remains sealed until the contents are about to be used on a patient. All of the devices are used for a single procedure on a single patient. If some materials are unused in that procedure, they are discarded. In this example, the single-use disposable medical procedure kit qualifies as a convenience kit.
For more information about the new guidance, review the FDA’s document in its entirety.