The FDA requires that medical device manufacturers submit a new 510(k) when a marketed device has changes, including changes to software, that could significantly affect the safety or effectiveness of the device or when there are major changes in the intended use of the device.
This wizard codifies the FDA guidance document "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" to help you assess whether your changes are significant and therefore will result in a new 510(k).
