If a company seeks to make a significant change to its device's fundamental scientific technology, how should this change be filed with the FDA?

When a company seeks to make a significant change to its device's fundamental scientific technology, the correct approach for filing with the FDA is through a Traditional 510(k). This pathway is designed for devices that have undergone substantial modifications, which may impact safety and effectiveness.

A Traditional 510(k) submission is required when changes are made that alter the intended use, fundamental technology, or control mechanisms of the device. These modifications often necessitate a more thorough review since they could significantly affect the device's performance, safety, or efficacy. The Traditional 510(k) submission involves presenting comprehensive data that demonstrates the modified device is substantially equivalent to a predicate device, highlighting how the changes impact the device's performance compared to the original design.

In contrast, a Special 510(k) is typically reserved for modifications that do not significantly impact the device's intended use or performance, while the Abbreviated 510(k) leverages existing guidance documents or performance data to provide evidence of substantial equivalence for changes that can be shown through existing methods. A Premarket Approval (PMA) is a more elaborate process required for high-risk devices, which does not align with the context of making changes via the 510(k) process.

Therefore, for significant fundamental changes,