Michael Falco - Comment

This comment is being submitted in relation to convenience kits and the proposed requirements outlined in parts 801.25(c) and 801.25(d). Currently this proposed regulation indicates that convenience kits consisting of multiple devices must be marked with a UDI and that all device packaging for all devices contained within the convenience kits must be marked with UDI, with the exception of single use devices. This proposed rule does not specify if devices that normally would not require UDI marking would be required to have UDI if they are then included in a convenience kit when they are intended for multiple uses. For example, if a convenience kit is assembled that contains devices that are normally all OTC devices, but the kit also includes a prescription device that must have a UDI, the law does not specify if the normally exempt, retail devices would now need to be marked with UDI, or if only the UDI of the single prescription device would be required on the convenience kit packaging. A real world example of this type of kit would be if a stethoscope was included in a convenience kit or medical instrument kit that contained a prescription device. Stethoscopes are generally sold at retail, and would normally be exempt from the UDI requirement, but it is not clear in the way this part is stated if such a device would now require a UDI as a result of its inclusion in such a kit. The wording of part 801.25(b), which is applicable to combination products rather than convenience kits, more adequately addresses this sort of situation when it occurs in relation to such a combination product by stating: “and regardless of whether the combination product is required to have a UDI,” It would be beneficial if parts 801.25(c) and 801.25(d) more clearly stated whether or not normally exempt devices would now require a UDI when included in a convenience kit with devices that do require a UDI, or if the exemption is still applicable.