Multiple-Use Devices
Devices intended for multiple use, and intended to be reprocessed before each use, will likely have their original packaging discarded when the device is first used. Therefore, these devices must bear a Unique Device Identifier (UDI) as a permanent marking on the device itself, so that the UDI can be maintained throughout the product’s lifetime. The UDI provided through a direct marking on a device may be identical to the UDI that appears on the label of the device, or it may be a different UDI used to indicate specifically the unpackaged device.
The requirement for direct marking of UDIs will not apply where:
- Any type of direct marking would interfere with the safety or effectiveness of the device;
- It is not technologically feasible to directly mark the device;
- The device is a single-use device and is subjected to additional processing and manufacturing for the purpose of an additional single use.
- The device has been previously marked.
Life-sustaining or life-supporting devices that require directly-marked UDIs must comply by September 24, 2015. Class III devices that require directly-marked UDIs must comply by September 24, 2016. Class II devices that require directly-marked UDIs must comply by September 24, 2018.
UDI Labeling of Stand-Alone Software
Stand-alone software must have a UDI, regardless of whether it is distributed in packaged form or downloaded from a website. Such software will meet the requirement if it displays the UDI in (1) an easily readable plain-text statement displayed whenever the software is started; or (2) an easily readable plain-text statement displayed through a menu command (e.g., an “About * * *” command).
The compliance deadline for UDI labeling of life-sustaining or life-supporting software is September 24, 2015.
Combination Products and Convenience Kits
Combination products contain a device and a drug and/or biologic product. Convenience kits typically contain several devices common to a single medical procedure, and sometimes also contain a drug and/or biologic. The individual device components of combination products or convenience kits do not need UDIs on their labels, as long as the label of the immediate container of the combination product or convenience kit bears a UDI.
If a combination product has an NDC number, the label for the entire combination product is not required to also have a UDI. However, each device constituent of such a combination product must bear a UDI, unless the UDI is on the immediate container of the combination product, as required above, or the drug, device, and/or biologic components are combined or mixed as a single entity.
