New Draft Guidance Clarifies UDI Exceptions for Convenience KitsJanuary 15, 2016
By Allyson B. Mullen –
On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule. The guidance is quick to point out that the convenience kit definition used in the draft guidance relates to the UDI requirements only, and does not change any other FDA statements regarding what constitutes a convenience kit (e.g., “Convenience Kits Interim Regulatory Guidance” May 20, 1997). The question of what is a convenience kit is ripe for its own updated guidance.
The draft guidance defines a convenience kit for purposes of the UDI rule as being “two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.” This definition is important because if a kit meets the definition of a convenience kit then only the kit label is required to include a UDI and the individual devices within the kit are exempt from the requirement to bear a UDI. 21 C.F.R. § 801.30(a)(11). If a kit does not meet the definition then each individual device in the kit will be required to comply with the applicable UDI requirements.
The guidance further elaborates on what it means by the devices being “packaged together.” FDA indicates that devices are packaged together if the devices are “packed (i.e., wrapped or sealed) in a single container that is not intended to be unwrapped or unsealed before it is used by an end user.”
The heart of the draft guidance consists of several examples to illustrate kits that do and do not meet the definition of a convenience kit for purpose of the UDI rule:
- First aid kit – Convenience Kit. The first aid kit meets the definition because the bandages, scissors, etc., are sealed in a single package and are not unpackaged until they are used by the end user.
- Non-sterile orthopedic device tray or set – Not a Convenience Kit. A non-sterile tray consisting of numerous instruments and implants of various sizes that requires sterilization before use and the unused components from which can be used in another subsequent tray would not meet the definition. This kit does not meet the definition because the components do not remain packaged together prior to use by the end user as they must be unpackaged for sterilization prior to use. In addition, the unused implants and/or reusable instruments can be reprocessed/resterilized and used in a subsequent tray. Thus, these potentially unused components, which may be used later, will not remain packaged with the other components prior to use.
- ACL disposable procedure kit – Convenience Kit. A sterile procedure kit consisting of various instruments, guide wires, graft passers, etc. would meet the definition because the components all remain packaged together up until the point in time when the surgeon opens the tray for use on the patient.
- Reusable medical devices packaged together – Not a Convenience Kit. This example describes non-sterile, reusable surgical instruments packaged together. The draft guidance explains that these co-packaged instruments do not meet the definition of a convenience kit because they would have to be separated prior to use in order to be sterilized. FDA’s rationale appears linked to the device’s need for sterilization rather than the fact that the instruments are reusable, as described in the example title. This ambiguity leads us to wonder whether a kit consisting of reusable devices that did not require sterilization would meet the definition. For example, the first aid kit example contains some devices that are reusable (e.g., scissors, thermometer), and the fact that the devices are reusable does not seem to alter FDA’s analysis in that example. Thus, it appears that meeting the definition – at least in this example – turns on the devices requiring sterilization rather than being reusable.
A few key points regarding the convenience kit definition that we can take from the guidance’s definition and the illustrative examples:
- The contents of the convenience kit do not need to be consumed in a single instance. For example, the contents of the first aid kit will be used over time, but it is still a convenience kit, at least for purposes of the UDI rule.
- Whether a kit is a convenience kit for purposes of UDI is based on the manufacturer’s intent. In the first aid kit example, the manufacturer intends for the kit to remain packaged together prior to use in accordance with the convenience kit definition. The guidance acknowledges, however, that it is likely the purchaser could replace devices originally provided in the kit as they are consumed (e.g., bandages). Because the manufacturer is not doing the replacement and the manufacturer intends for the kit to remain packaged together prior to use, the kit meets the convenience kit definition. It would be interesting to see if FDA would still agree with this position if the example were a higher risk kit.Note: FDA’s proposal to focus on the manufacturer’s intent is consistent with the proposal issued last year on amending the intended use regulation (21 C.F.R. § 801.4) to remove the concept of known off-label use requiring additional labeling to address such use. 80 Fed. Reg. 57756 (Sept. 25, 2015).
- If any devices in the kit require sterilization prior to use, the kit cannot be a convenience kit because the devices must be unpackaged prior to use. The guidance only addresses sterilization, but in our view, it is possible that other processing or preparation could cause a kit to not meet the convenience kit definition.