On January 4, 2016, FDA officially released a draft guidance document Unique Device Identification: Convenience Kits, with further information regarding the Unique Device Identifier (UDI) requirements for labeling and data submission for kits. This guidance provides further clarification to the UDI rule which was finalized in 2014. While the original rule included certain discussion of kits, it failed to address many situations, particularly those kits that are replenished and/or reprocessed after leaving the manufacturers control, whether sold, consigned, or loaned to hospitals. This draft guidance reinterprets the definition of Convenience Kits for purposes of the UDI requirements to be narrower than both the definition provided in the regulation (21 CFR § 801.3) and the definition used to determine whether a Convenience Kit requires premarket clearance or approval in the agency’s 1997 Convenience Kits Interim Regulatory Guidance.
The UDI Rule
The UDI Rule requires labelers to comply with UDI labeling and data submission requirements, including that the label and each device package of a medical device distributed in the United States bear a UDI, unless an exception or alternative applies. One of the exceptions defined by the UDI Rule states that individual devices packaged within a Convenience Kit are excepted from the UDI labeling requirements of 21 CFR § 801.20, provided that a UDI is on the label of the immediate container of the Convenience Kit (21 CFR § 801.30(a)(11)). The term “Convenience Kit” is defined at 21 CFR § 801.3 as “two or more different medical devices packaged together for the convenience of the user.”
In 2014 and 2015, an AdvaMed working group comprised of orthopedic industry leaders approached FDA with UDI implementation concerns related to the distribution of orthopedic implants and instruments in surgical sets. Specifically, the group noted that it understood the intent of the law to ensure that UDI information for each device was available at the point of use, but that the long standing distribution model in the orthopedic industry created unique challenges to meeting the objectives of the UDI Rule. To address the needs of surgeons to have various sized implants and instruments available at the time of surgery to accommodate differences is patient anatomy, the orthopedic industry developed surgical sets that are configurable and can contain hundreds of implants and instruments. These surgical sets are designed to be extremely durable and are configured to be replenished and reprocessed/sterilized at the hospital prior to use. As a part of the replenishment process, the packaging for implant devices is often discarded as the device (e.g., instrument, implant) is placed into the surgical set and readied for sterilization. Thus, the packaging and labeling for the implants and instruments contained in the sets, including UDI information, would not be available in the surgical suite at the point of implantation. The group expressed its desire to comply with the UDI Rule, but that implementation was complex and time consuming and to be done well (i.e., in order to conduct the necessary development, testing, validation, FDA clearances/approvals as needed, and facilitating adoption by the health care community) without interfering with the delivery of healthcare, the industry would require more time than was permitted by the agency’s planned implementation dates.
FDA acknowledged the challenges, and responded by granting certain defined product codes of single use orthopedic implants that were intended to be sterilized (or cleaned and sterilized) before use a 1 year extension for compliance for placing UDI information on the labels, though such products were still required to meet the UDI database requirements.1 In its extension letter, the agency reiterated that the intent of the rule is that the UDI information is accessible at the point of use of the device.
New Convenience Kit Draft Guidance
This new Convenience Kit draft guidance further confirms this general principle that the UDI information be accessible at the point of use of the device. Specifically, the draft guidance states:
“The overarching objective of the UDI Rule, as required by section 519(f) of the FD&C Act, is to provide a system to adequately identify medical devices through distribution and use. We interpret this to mean that the form of a UDI should, in conformity with 21 CFR 801.40, be available to identify a device in both easily readable plain-text and in a form that can be entered into an electronic patient record or other computer system via an automated process when the device is used by an end user. The term “end user” means the individual using the device on or on behalf of a patient (e.g., the patient, a caregiver, healthcare practitioner, or clinical laboratory technologist).”
The guidance goes on to clarify what is appropriately considered a ”Convenience Kit” for purposes of utilizing the exception in 21 CFR § 801.30(a)(11) allowing individual components of kits to not include UDI information provided that the overall kit is labeled. Specifically, the draft guidance states that this exception would not apply in situations where the kit components are “not intended to remain packaged together and/or are intended to be replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user […]” as placing UDI information on the kit label alone would not adequately identify medical devices through distribution and use as some components of the kit may be replaced.
Consistent with these principles, the draft guidance proposes to reinterpret the term “Convenience Kit” in 21 CFR § 801.3 for purposes of UDI compliance to apply “solely to 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” (emphasis added).This definition is narrower than how the agency has defined the term “Convenience Kit” as it relates to whether a new 510(k) would be required for kits “comprised of legally marketed devices that are simply being assembled in kit form strictly for the ‘convenience’ of the purchaser or user,” which was the basis for the definition in 21 CFR § 801.3.2
FDA elaborates in the draft guidance Question & Answer section that all devices packaged within a Convenience Kit do not need to be consumed in a single use, but the kit components cannot be intended to be replaced, substituted, repackaged, sterilized, or otherwise processed or modified before being used by an end user in order to remain eligible for the UDI labeling exception. This position is similar to how FDA has previously interpreted other exceptions, in line with the goal that the UDI information is available at the point of use. For example, FDA’s guidance Unique Device Identification System: Small Entity Compliance Guide previously clarified that the exception for individual single-use devices of a single model which are distributed together in single device package, and which are not intended for individual commercial distribution, provided that the overall outer package has UDI information, only applies where the individual devices are intended to be stored in the labeled device package until removed for use. Accordingly, FDA’s approach in the new draft Convenience Kits guidance appears to square with the agency’s approach in other circumstances in that the devices’ labeling must be available at the point of use.
The current draft guidance provides some limited examples of what FDA considers to be a Convenience Kit, consistent with its proposed more restrictive definition. A sealed first aid kit and a disposable ACL surgical kit would both fall within the proposed definition of a Convenience Kit as these products are either single use or the kit components are intended to remain stored within the kit and the individual components are not intended to be replaced when used. In contrast, kits, where the components are repeatedly reconfigured, replenished or processed (e.g., sterilized) prior to use, such as non-sterile orthopedic device trays would not qualify as a Convenience Kit for purposes of the UDI exception in 21 CFR § 801.30. Accordingly, each component of the kit will need a UDI available for capture at point of use. Additionally, consistent with the requirements of 21 CFR § 801.45, any devices which are intended to be used more than once and intended to be reprocessed before each use will need to be directly marked with UDI information.
The guidance document also goes on to clarify that the Convenience Kit itself is a medical device, which requires a UDI, thus implying that regardless of whether companies choose to apply the exception in 21 CFR § 801.30(a)(11) regarding labeling the components of the Convenience Kit, the kit itself would require a UDI. Notably, this would apply to all kits, and not just the Convenience Kits that are the primary subject of this draft guidance. In its Question & Answer section, FDA makes clear that for UDIs placed on the kits, there are limits to the amount of variation would be allowed in the kit components for Convenience Kits identified by the same device identifier (DI). FDA states that “under 21 CFR § 830.50, whenever you make a change to a device that is required to bear a UDI on its label, and the change results in a new version or model, you must assign a new DI to the new version or model. A new version or model of a Convenience Kit results when the change to the convenience kit requires documenting this change in the device master record.” For certain types of kits that are deliberately designed to be highly configurable, to satisfy the requirement for a device identifier for the kit, rather than the individual components, may well necessitate the need for limits on the configurations of the surgical sets, or hundreds of different DIs, or both.
While the guidance reinforces that manufacturers must ensure that the UDI information will reasonably be accessible at the point of use for each device, the draft guidance does not offer any additional relief or solutions to manufacturers that must figure out how to get the UDI information to the point of use in a way that does not interfere with the device, processing (such as sterilization), usage, or the delivery of healthcare. The challenges are further compounded by the roles of distributors and hospitals in performing replenishment and reprocessing of kits, thereby limiting the amount of control the manufacturers have once the kits first leave its control. Finally, although the guidance proposes to reinterpret the definition of “Convenience Kit” in the regulation, it does not mention an intention to do so through an amendment to the UDI regulation, but rather, it appears, by interpretation alone.
Comments on the draft guidance are being accepted through April 3, 2016.