Recently, the FDA issued the final guidance, “Unique Device Identification: Convenience Kits” to help clarify the FDA’s policy related to UDI considerations for medical procedure kits. The intent of this guidance is to ensure that the exception for UDI labeling of devices within the immediate container of a convenience kit is applied in a way that provides adequate identification of devices through distribution and use.
The FDA provided a Q&A section to help manufactures determine when individual components of a kit require labeling.
Q. To be considered a convenience kit for purposes of the UDI regulations, should all the devices within a container be finished devices?
A. Yes. We interpret “medical devices” in the definition of “convenience kit” in 21 CFR 801.3 (“two or more different medical devices packaged together for the convenience of the user”) to mean finished devices and not device components. Finished devices are defined by21 CFR 801.3 as “any device or accessory to any device that is suitable for use or capable of functioning.”
Q. How much variation is allowed for different convenience kits to be identified by the same device identifier (DI)? If I substitute one device for another, will the kit need a new DI?
A. It is up to the labeler to determine when a change to a model or version of device results in a new model or version of the device. 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.
Q. If all the devices in a container are not intended to be consumed in a single use or used at the same time, can this be a convenience kit?
A. Yes. If devices packaged together otherwise meet the definition of a convenience kit for UDI compliance purposes, all the contents of the kit need not be intended to be consumed in a single use or used at the same time to be considered a convenience kit.
Q. What production identifiers (PIs) must be included in the convenience kit UDI?
A. The convenience kit is itself a device. The UDI of the convenience kit must include any PIs on the convenience kit label that are required by21 CFR 801.40(b).
Q. If my device meets the UDI labeling exception for a convenience kit under 21 CFR 801.30(a) (11), may I still place a UDI on individual devices or device labels in the kit?
A. Yes, 21 CFR 801.30(a) (11) is an available exception, not a requirement. You may place UDIs on devices or device labels within a convenience kit. If any individual devices with UDIs on the devices or device labels are included in a convenience kit, it may be useful to reference the DIs of the individual devices within the device identifier (DI) record for the convenience kit that is submitted to the Global Unique Device Identification Database (GUDID). Stakeholders using Access GUDID, the public portal for GUDID, often find it useful to know whether or not there will be a label to scan on devices in a kit and to have access to the additional information in the DI records of the kit.
Q. Are there any special rules for creating a DI record in the GUDID for a convenience kit?
A. For technical recommendations on how to submit information to GUDID, including information relating to convenience kits, please visit FDA’s website.
Be sure to bookmark the Innovit blog page for more news/info.