Final Guidance on UDI Labeling for Convenience Kits Brings Additional Clarity

Last week FDA issued a final guidance, Unique Device Identification: Convenience Kits, which clarifies FDA’s interpretation of a convenience kit for purposes of UDI labeling requirements.  We previously blogged on the draft version here.   As our readers know, the unique device identification system regulations require that the label and device package of a device must bear a UDI, unless an exception or alternative applies.  One such exception is for devices packaged within the immediate container of a convenience kit if the label of the convenience kit bears a UDI.  21 C.F.R. § 801.30(a)(11).

Unchanged from the draft guidance is FDA’s definition of a convenience kit: A convenience kit is “two or more different medical devices packaged together for the convenience of the user” (21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.  FDA clarifies that “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.  Notably, the guidance does not apply to kits that contain devices co-packaged with drugs.

Kits that meet the definition of a “convenience kit” must include a UDI on the kit label and the individual devices within the kit are exempt from the requirement to bear a UDI.  21 C.F.R. § 801.30(a)(11).  Medical devices that are a part of kits that do not meet this definition must be individually labeled in accordance with applicable UDI requirements.

The final guidance includes additional examples and clarifications:

• First aid kits

Like the draft, the final guidance concludes that a first aid kit meets the definition of a convenience kit because the bandages, scissors, etc., are sealed in a single package and are not unpackaged until they are used by the end user.  Those components would not need to be individually labeled with a UDI, as long as a UDI is affixed to the immediate container of the kit.  The final guidance adds that end users may wish to replenish components of the first aid kit, rather than purchasing a new one as supplies run out.  In that case, the individual devices used to replenish or augment the first aid kit must bear a UDI because they were not part of the original convenience kit.

• Non-sterile orthopedic device set

This example is largely the same, with only stylistic differences from the draft.  As before, a collection of orthopedic implants and reusable instruments that are all supplied as non-sterile would not meet the definition of a convenience kit for UDI purposes.  Each of these devices is removed from its packaging and placed into a sterilization tray for cleaning and sterilization at some point prior to use.  Potentially unused components, which may be used later, will not remain packaged with the other components prior to use.  Therefore, each device in the set must comply with all applicable UDI labeling, data submission, and direct mark requirements.

• Single use disposable medical procedure kit

This example is also largely unchanged.  A sterile procedure kit consisting of various instruments, guide wires, graft passers, etc. would meet the definition of a convenience kit because the components all remain packaged together up until the point in time when the surgeon opens the tray for use on the patient.  The final guidance adds that this example is distinguishable from Example 2, in which the devices are intended to be sterilized prior to use and intended to be reassembled and restocked between uses.

• Sterile kit containing both single-use and reusable medical devices packaged together

This is a new example in the final guidance.  In this example, FDA describes a suture kit which 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.  FDA would consider this 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, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.  FDA notes, however, that because some devices in the kit are intended to be reprocessed and reused, those devices would be subject to direct mark requirements under 21 C.F.R. § 801.45.

• Different devices packaged together for the convenience of the user but the collection of devices is not itself a device

This is also a new example in the final guidance.  In this example, 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 considered a convenience kit for UDI purposes because the devices packaged together are not collectively a device.

A few key points regarding this final guidance:

These additional examples help to clarify some of the takeaways we previously reported.  For example, the draft guidance implied that if any devices in a kit required sterilization prior to use, it could not be considered a convenience kit.  Based on the fourth example in the final guidance, however, there is a noteworthy exemption from this general rule.  If the product is initially provided as sterile, but requires sterilization after its first use, FDA would consider this a convenience kit.

We also note, as we did in our previous post, that the intent of the labeler informs the determination of whether a kit is a convenience kit for UDI purposes.  How the product is used has no bearing on the analysis.