Questions & Answers from the Draft Guidance:
1. To be considered a convenience kit for UDI purposes, should all of the devices within a container be finished devices?
Yes. We interpret “medical devices” in the definition of “convenience kit” at 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 by 21 CFR 801.3 as “any device or accessory to any device that is suitable for use or capable of functioning,” in contrast to components, defined by 21 CFR 820.3(c) as “any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.” Components packaged together for assembly would not be packaged together for the convenience of the user. While a container of device components intended to be assembled into a single device may be considered a single device requiring a UDI (that is, a UDI is required on the label of the immediate container but not on the individual components), it does not fit the definition of convenience kit for UDI requirements.
2. How much variation is allowed for different convenience kits to be identified by the same device identifier (DI)? If I substitute one component for another, will the kit need a new DI?
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.
3. 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?
Yes. If devices packaged together otherwise meet the definition of a convenience kit for UDI compliance purposes, all of the contents of the kit need not be intended to be consumed in a single use or used at the same time in order to be considered a convenience kit. Example 1 is a convenience kit despite the fact that all the individual devices may not be intended to be consumed in a single use. In that example, the devices within the first aid kit are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before use by an end user.
4. If devices in a container are intended to be restocked by the labeler, would this still be a convenience kit?
No. In order to be a convenience kit as defined by 21 CFR 801.3, the immediate container cannot be intended to be opened and the individual devices replaced, substituted, repackaged, sterilized, or otherwise processed or modified before being used by an end user. In Example 1 the devices in the first aid kit are intended remain packaged together and not replaced; although the purchaser may replace devices consumed over time, such as bandages, this replacement is not intended by the labeler to occur prior to use by an end user.
5. What production identifiers (PIs) must be included in the convenience kit UDI?
The convenience kit is itself a device. The UDI of the convenience kit must include any PIs that are required by 21 CFR 801.40(b).
6. 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?
Yes. 21 CFR 801.30(a)(11) is an exception, not a requirement. You may place UDIs on devices or device labels within a convenience kit. If individual devices with UDIs on the devices or device labels are included in a convenience kit, the device identifier (DI) record for the convenience kit submitted to the Global Unique Device Identification Database (GUDID) should include the DI for the kit itself and not the DIs for the individual devices in the kit. However, the individual device DIs may be included in the Device Description.
7. Are there any special rules for creating a DI record in the GUDID for a convenience kit?
When entering information in the GUDID for a convenience kit, you should check the “Kit” box. Also, if the convenience kit is packaged individually, the base device count should be “1”. A Unit of Use DI is not required for each device packaged within the immediate container of the convenience kit. For more details, go to GUDID Data Elements Reference Table.
8. How do I describe the devices within the convenience kit in the GUDID?
We encourage you to submit information about the convenience kit itself, as well as information about the devices packaged within the convenience kit, in the “Device Description” field of the GUDID.
*As stated in the FDA’s draft guidance entitled, “Unique Device Identification: Convenience Kits .”