If you modified your 510(k) cleared device with a special 510(k), when would you need to create a new listing?

In the context of a special 510(k), the need to create a new listing for a medical device primarily arises from changes that significantly impact the safety and effectiveness of the device. Modifications such as adding new sizes and shapes, changing the material composition, or altering the packaging of the device are generally not considered substantial enough to require a new listing under certain circumstances if they do not affect the device’s intended use or performance.

When a manufacturer submits a special 510(k), they are typically leveraging the streamlined process to demonstrate that the changes made to the device are not significant enough to warrant a full 510(k) submission. As long as the modifications do not alter the fundamental performance or intended use of the device and compliance with existing regulatory requirements is maintained, it is possible that none of these changes would necessitate a new listing.

Thus, if the modifications fall within acceptable guidelines, creating a new listing would not be required, leading to the conclusion that selecting "none of the above" is appropriate in this scenario.