The Food and Drug Administration announced on April 25, its final guidance: “Unique Device Identification: Convenience Kits,” which the agency says gives its interpretation of the definition of “convenience kit” for sole purposes of applying unique device identifier (UDI) requirements.
The document clarifies the FDA’s policy related to UDI considerations for “medical procedure kits” and helps ensure that the exception for UDI labeling of devices within the immediate container of a convenience kit is applied in a way that provides adequate identification of devices through distribution and use. FDA offers five examples of the types of convenience kits that will require UDI compliance.
According to FDA’s 21 CFR 801.3 a convenience kit is “two or more different medical devices packaged together for the convenience of the user.” FDA said in the announcement that the agency “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.”
What follows are some brief examples of what is contained in various types of convenience kits for purposes of FDA’s unique device identification system requirements, including UDI labeling and data and submission requirements.
Retail first aid kit: A first aid kit sold at retail that includes only devices—such as bandages, cold compresses, scissors, and an oral thermometer—packaged together is a convenience kit. It is a device that contains two or more different medical devices that are packaged together for the convenience of the user 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. Therefore, the label of each individual device within the container is not required to bear a UDI, provided that a UDI is available on the label affixed to the immediate container of the kit.
After purchasing a first aid kit, the end user may choose to replenish devices or add more devices over time, rather than purchasing a new first aid kit. A labeler may choose to market individual devices separately to the end user. In such cases, the label and device package of the individual devices that may be used to replenish or augment the first aid kit must bear a UDI because they are not part of the convenience kit.
Non-sterile orthopedic device set: A collection of orthopedic devices comprises implants and reusable instruments that are all supplied non-sterile. Each of these devices is removed from its packaging to be placed into a sterilization tray for cleaning and sterilization at some point prior to use, as intended by the labeler. Only a few of the implants in each set may be selected for implantation in a single procedure on a single patient. After the procedure, the sets are replenished with different implants, replacing those used during the procedure. The sterilization tray, the replacement implants, the implants that were in the sterilization tray prior to the procedure and not chosen for surgical use, and the reusable instruments, are all sterilized for potential use in subsequent surgical cases. This is not a convenience kit because the devices are not intended to remain packaged together without undergoing sterilization before being used by an end user. Therefore, each device must comply with all applicable UDI labeling, data submission, and direct mark requirements.
Single use disposable medical procedure kit: A single use, disposable medical procedure kit, such as an anterior cruciate ligament (ACL) procedure kit, comprises sterile, single use instruments such as guide wires, drill tip guide pins, tunnel plugs, and a graft passer that are used for ACL reconstruction procedures. The kit comprises devices that are packaged and sealed in a single container, and the container is supplied sterile. The container is intended to remain sealed and the contents sterile until the contents are about to be used on a patient. All the devices are used for a single procedure on a single patient, or, if unused after a single procedure on a single patient, disposed of without being used because sterility has been compromised. This single use disposable medical procedure kit is a convenience kit because it is a device comprising individual devices packaged together for the convenience of the user and not intended to be replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user. Therefore, the label of each individual device within the container is not required to bear a UDI, provided that a UDI is available on the label affixed to the immediate container of the kit.
Sterile kit containing both single-use and reusable medical devices packaged together: A suture kit contains single-use sutures and reusable stainless-steel instruments, including forceps, needle holders, and scissors. The kit is supplied sterile, but after the initial procedure in which the single use device (suture) is consumed, the labeler intends that the instruments may be reused on different patients, which requires reprocessing before each subsequent use. This is a convenience kit because the individual devices within the device are packaged together for the convenience of the user and not intended to be replaced, not required to bear a UDI, provided that a UDI is available on the label affixed to the immediate container of the kit.
In this example, some devices in the kit are intended by the labeler to be reprocessed and reused, and therefore those reusable devices are subject to direct mark requirements (21 CFR 801.45).
Different devices that are packaged together for the convenience of the user, but the collection of devices is not itself a device: A labeler manufactures fluid-filled teething rings in a variety of shapes. The labeler packages one teething ring of each shape together as a fixed quantity to create an item for retail with a higher profit margin and/or to allow each end user to select and use a particular model of teething ring according to preference. This is not a convenience kit because the devices packaged together are not collectively a device. substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user. Therefore, the label of each individual device within the container is not required to bear a UDI, provided that a UDI is available on the label affixed to the immediate container of the kit.
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