Pop quiz: For the purposes of FDA Unique Device Identification (UDI), is an anterior cruciate ligament (ACL) procedure kit considered one medical device, i.e., a “convenience kit?” That question is one of many addressed by the FDA’s final guidance on Unique Device Identification: Convenience Kits published in April 2019.
As a refresher, FDA’s UDI system sets a standard for identifying all medical devices sold in the U.S. from the time they are manufactured through the distribution process to the point of patient care. UDI requires device labels and packaging to have a unique device identifier in a form readable by both humans and machines. The goals of UDI include improving patient safety, modernizing surveillance of devices once they are in the market, and facilitating innovation in medical devices. Clear identification can also improve the standardization of the appropriate use of medical devices.
Convenience kits – which FDA defines as “two or more different medical devices packaged together for the convenience of the user” (21 CFR 801.3) – represent a slight exception to the rule. When multiple medical devices are packaged together for commercial distribution and meant to remain that way until being used on a patient, they can be treated as a single medical device and labeled as such with one UDI. The contents of a convenience kit must not be replaced, substituted, repackaged, sterilized or otherwise processed or changed before being used by the end-user. They also cannot be reused after an initial use to classify as a convenience kit.
While some propose that convenience kits should not fall under UDI regulations, the FDA has made it clear that these labels are crucial for the effectiveness of the UDI system. With such wide use, removing convenience kits from UDI jurisdiction would leave a large gap in patient protection and in-field product tracking.
Importantly, the final guidance clarifies that not every collection of devices packaged together will meet the criteria: “For purposes of the UDI regulations, the FDA does not consider every medical procedure kit, nor every collection of two or more medical devices, to be a ‘convenience kit.’” Section 801.30(a)(11) also clarified that a device packaged within the immediate container of any convenience kit or within the immediate container of a combination product will not be required to bear a UDI label, provided that the label of the combination product or convenience kit bears a UDI.
The final guidance uses five examples to illustrate what could be labeled as a convenience kit and what would still require UDI for individual components:
Example 1 – Retail first aid kit
The FDA clearly states that a first aid kit containing only devices packaged only together (bandages, cold compresses, scissors, an oral thermometer) can be considered a convenience kit. This first aid kit would, therefore, need only one UDI for its label and packaging. Once a consumer brings a first aid kit home, she might decide to replenish supplies over time. Those replacement devices would all need to have their own UDI.
Example 2 – Non-sterile orthopedic device set
FDA’s guidance explains that a collection of orthopedic devices with implants and reusable instruments – all supplied non-sterile – would NOT be considered a convenience kit. That’s because each of those components would have to be cleaned and sterilized before use. In addition, typically the used implants are replenished with new items and the complete procedure kit is cleaned and sterilized for the next surgical procedure. These processes are outside the scope of a convenience kit. Bottom line: While this collection of devices can be considered a “medical procedure kit,” it cannot be treated as a convenience kit. Each item must bear a UDI with the reusable instruments also qualifying for UDI direct marking. This protects patients as any found faults in the components could more easily be identified, recalled, and corrected.
Example 3 – Single-use disposable medical procedure kit
The FDA cites an ACL procedure kit supplied in a sterile container as an example of a single-use disposable medical procedure kit. The guidance notes that in this case, the medical procedure kit is also a convenience kit because it meets all the qualifying criteria. The crucial difference from Example 2: The procedure kit is supplied sterile and no devices are replaced – anything left over is disposed of without being reused. This kit is intended to be used as one whole, not individual pieces.
Example 4 – Sterile kit with both single-use and reusable medical devices packaged together
What happens when a sterile package combines both single-use and reusable devices? The FDA mentions a suture kit as an example, as it contains single-use sutures as well as reusable forceps, needle holders and scissors. The guidance affirms that this collection can, in fact, be labeled with one UDI as a convenience kit. However, any reusable components – including the stainless-steel instruments listed above – must comply with direct mark requirements. In other words, anything that could be reprocessed and reused must be able to stand alone from a labeling perspective.
Example 5 – Different devices packaged together for the convenience of the user, but the collection of devices is not itself a device
For this example, the FDA points to fluid-filled teething rings that come in a variety of shapes. The labeler might package one ring of each type together to create a higher-profit item at retail or to give consumers greater choice. As you can probably guess, this packaging would not qualify as a convenience kit because the devices packaged together are not collectively a single device. Each teething ring would need a separate UDI.
Note: In vitro diagnostic (IVD) devices are still subject to IVD labeling requirements under 21 CFR part 809 and do not fall under the FDA’s convenience kit guidance. Combination products as defined by 21 CFR 3.2(e) are also excluded.
Ready to pass the test when it comes to UDI and convenience kits? As you are navigating the guidance and completing UDI requirements, Reed Tech is available to help with our SingleSource™ for Medical Devices. Expert Reed Tech staff work with your regulatory team to smoothly navigate each stage of UDI data submission – a model that’s especially “convenient” if you have limited staff resources to devote to UDI data compliance.