Unique Device Identification (UDI) for Convenience Kits
FDA had implemented unique device identifier (UDI) for different types of medical devices. Marking UDI on the convenience kits label has been a question for manufactures, since it contains individual devices packaged in a kit. FDA had issued a final guideline on Unique Device Identification for Convenience Kits on April 26, 2019. According to FDA, convenience kits itself is considered as medical device and it is required to be labeled with UDI.
With respect to the UDI, FDA defines convenience kit as a device that contains two or more different medical devices packaged together and intended to remain packed together and not to be replaced, substituted, repackaged, sterilized, or otherwise processed or modified before being used by an end user.
As per FDA's new guideline, label of each individual device packaged within the immediate container of a convenience kit are exempted from UDI requirements provided that the UDI is available on the label of the kit. However, the individual devices require the UDI if the labeler markets the individual devices separately as well. If the convenience kit is combination product with an NDC number (i.e. primary mode of action of the kit is that of a drug ) and it is physically, chemically, or otherwise combined or mixed and produced as a single entity and the device constituent part cannot be used separately, except as part of the combination product, then the kit is exempted from the requirements of UDI.
UDI for Non-sterile orthopedic device set
The Non-sterile orthopedic device set which contains implants and reusable instruments that are all supplied non-sterile cannot be considered as convenience kit. The devices need to be sterilized prior to use and only a few of the implants in each set may be selected for implantation in a single procedure on a single patient. Hence, FDA does not consider this type of kit under the definition of convenience kit and each individual device packed in such kits need to be complied with UDI requirements.
UDI for Suture Kit containing single-use and reusable devices
A suture kit containing single-use sutures and reusable stainless-steel instruments also can be considered as a convenience kit. In this case, the label of single-use sutures within the container is not required to bear UDI, if a UDI is available on the label of the kit and UDI is directly marked on the reusable stainless-steel instruments. As per FDA, reusable devices need direct marking of UDI on the devices itself.