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UDI Exceptions on Single Use Devices

Last week we discussed the extension the FDA has granted on the Unique Device Identifier (UDI) Class II Mandates. Similar to the extension there are also exceptions on single use devices that medical manufactures should be aware of.

The exception states that if you put a (UDI) on the next higher level of packaging you do not need to put the UDI on each individual single use device.

For example, within a package of 10 bandages each individual bandage is packaged as well. Each bandage is individually labeled and under normal circumstances a UDI would be included on the label. Due to the exception, if the device is stored and distributed in a box, shelf pack, or other type of container then a UDI on the higher level of packaging is sufficient for the purposes of visibility and trace-ability. There are other devices distributed in similar boxes where the single use device exception is not applicable. If the device is not a single use device then it will most likely require a UDI label on the individual device in addition to the next higher level of packaging.