On January 4, 2016, the FDA published a draft guidance entitled, “Unique Device Identification: Convenience Kits.” The draft guidance comes after the Agency’s 2013 final rule that established a unique identification system, and clarifies the FDA’s definition of the term “convenience kit.”
The UDI Rule
On September 24, 2013, the FDA published the final ‘UDI rule’ (21 CFR 801.20), which established “a unique device identification system, including unique device identifier (UDI) labeling and data submission requirements.” According to this rule, the label and associated packaging of a device must bear a UDI.
In the rule, the FDA states that there are a number of exceptions to the rule’s requirements. These exceptions are provided in:
Exception for Convenience Kits
Title 21 of the Code of Federal Regulations Part 801.30 (21 CFR 801.30) provides a number of exceptions to the UDI Rule (21 CFR 801.20). As such, 21 CFR 801.30 (a)(11) offers an exemption for convenience kits, stating that “devices packaged within the immediate container of a convenience kit are excepted from UDI labeling requirements, provided that the label of the convenience kit bears a UDI.”
Earlier this month, the Agency published a draft guidance that is intended to build upon its 2013 rule (21 CFR 801.30). The Agency is seeking to alter the definition of convenience kits, making it more narrow than originally set forth in its final rule.
In the recent document, FDA states that the term ‘convenience kit’ should include only “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.”
The draft guidance also states that the FDA interprets the term ‘packaged together’ to mean “packed (i.e., wrapped or sealed) in a single container that is not intended to be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.” Additionally, the Agency elaborates on who it considers the end user to be, stating that it is “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The FDA states that the “draft guidance is intended to define the term ‘convenience kit’ for purposes of compliance with UDI labeling and data submission requirements only.” The Agency closes with a number of questions and answers related to the contents of the document. More information on the questions and accompanying answers included in the draft guidance is available here.
Are you in the process of developing a convenience kit? Do you have a convenience kit on the market that may be effected by this regulation? We can help you ensure compliance of your medical device(s) and achieve a successful outcome with FDA. For more information about our services and how we can help you, contact us here.