Class II medical device manufacturers are plunging into the depths of the UDI Regulation and finding that some days more questions are raised than are answered. One question we’ve had at Qualitas Professional Services is if a UDI needs to be applied to a replacement part for a device.
To answer this, we must first determine if the part is considered an “accessory” or a “spare part.”
The FDA defines “accessory” as “a device that is intended to support, supplement, and/or augment the performance of one or more parent devices.” Support means to enable or facilitate the device to perform according to its intended use; Supplement is defined as adding a new function or new way of using the device; and Augment improves the performance of the device by enabling the device to perform its intended use more safely or effectively. Also, an item that doesn’t meet the definition of accessory shouldn’t be treated as an accessory simply because they may be used in conjunction with a device.
“Spare Parts” are defined as parts that are “supplied for replacement of existing components of a device” and so not change the characteristics or affect the performance of a device.
If you have a part that is on the Accessory/Spare Part teeter totter, ask these questions:
Does the part replace an existing component of the device without affecting the characteristics or performance of the device?
Can the device function properly & effectively without the part?
As an accessory, the part is subject to all parts of the UDI regulation.
As a spare part, the UDI regulation is not applicable.