Unique Device Identification Program: The FDA Finalizes Guidance for Convenience Kits!
FDA finalized the guidance, “Unique Device Identification: Convenience Kits,” which describes the FDA’s interpretation of the definition of “convenience kit” for purposes of applying unique device identifier (UDI) requirements only. This guidance does not apply to in vitro diagnostic (IVD) devices that are subject to the IVD labeling requirements under 21 CFR part 809, nor does it apply to combination products as defined in 21 CFR 3.2(e).
Terms clarified within this guidance apply only for purposes of this guidance document and the UDI regulations, and are not intended to be applied beyond the regulations and policies pertaining to the unique device identification system. This guidance does not define the term “convenience kit” for other regulatory purposes. Although FDA previously expressed thinking that medical procedure kits containing only devices are convenience kits, FDA believes that this policy requires clarification for consistency with the objective of the unique device identification system. For purposes of the UDI regulations, FDA does not consider every medical procedure kit, nor every collection of two or more medical devices, to be a “convenience kit.”
FDA provided the below interpretation and explanatory information for purposes of this guidance and the UDI regulations.
- 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.
- Packaged together: 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.
- End user: The end user is the individual using the device on or on behalf of a patient, e.g., the patient, a caregiver, a healthcare practitioner, or a medical technologist.
- Medical Procedure Kit: A medical procedure kit typically consists of one or more medical devices, packaged together to facilitate a single surgical or medical procedure. A medical procedure kit may be a convenience kit.
The FDA will host a webinar to share information and answer questions about the implementation of the final guidance on Tuesday, May 21, 2019; from 3:00 p.m. to 4:30 p.m., Registration is not necessary