FDA UDI for Medical Device Kits

Convenience kits must bear a UDI on the kit label and have their UDI data submitted to the FDA’s Global Unique Device Identification Database (GUDID)

21 CFR Part 830GUDID SubmissionKit LabelingSince 2009

UDI Requirements for Medical Device Kits

The FDA has implemented unique device identification (UDI) requirements for different types of medical devices. Marking UDI on a convenience kit’s label has been a common question for manufacturers, since a kit contains individual devices packaged together. The FDA issued a final guidance, “Unique Device Identification: Convenience Kits,” on April 26, 2019. According to the FDA, a convenience kit is itself considered a medical device and must be labeled with a UDI.

For UDI purposes, the FDA defines a convenience kit as two or more different medical devices packaged together and intended to remain packaged together — not to be replaced, substituted, repackaged, sterilized, or otherwise processed or modified before being used by an end user.

Under this guidance, the label of each individual device packaged within the immediate container of a convenience kit is exempt from UDI requirements, provided that a UDI appears on the label of the kit. However, those individual devices do require their own UDI if the labeler also markets them separately. In addition, if the convenience kit is a single-entity combination product that bears an NDC number — that is, the 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 such that the device constituent part cannot be used separately except as part of the combination product — then the kit is exempt from UDI requirements.

UDI for a Non-Sterile Orthopedic Device Set

A non-sterile orthopedic device set that contains implants and reusable instruments supplied non-sterile cannot be treated as a convenience kit. The devices must 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. For these reasons, the FDA does not consider this type of kit to fall within the definition of a convenience kit, and each individual device packaged in such a set must comply with UDI requirements.

UDI for a Suture Kit Containing Single-Use and Reusable Devices

A suture kit containing single-use sutures and reusable stainless-steel instruments can be considered a convenience kit. In this case, the label of the single-use sutures within the container is not required to bear a UDI, provided that a UDI appears on the label of the kit and the UDI is directly marked on the reusable stainless-steel instruments. According to the FDA, reusable devices intended to be reprocessed and reused require direct marking of the UDI on the device itself.