A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology. How should this change be filed?

The best approach for a company looking to modify a legally marketed device without affecting its intended use or the fundamental scientific technology is to utilize the Special 510(k) pathway. This pathway is specifically designed for situations where the modification does not raise new questions of safety or effectiveness. It allows manufacturers to submit a streamlined review for certain changes that can be demonstrated to be as safe and effective as the original device.

The Special 510(k) process emphasizes a more efficient review, enabling companies to file their modifications based on their own testing and validation done according to the applicable standards. This is particularly useful when the changes are minor and can be adequately substantiated with appropriate documentation rather than through extensive clinical data.

In contrast, the Abbreviated 510(k) route is used when the manufacturer can demonstrate that the device meets the relevant device-specific guidance, which may not directly apply here if the changes are straightforward modifications. The Traditional 510(k) is more comprehensive and is generally employed for changes that might raise new issues related to safety or effectiveness. The De Novo pathway is utilized for devices that are novel and do not have a predicate device, which would not be suitable for a modification to an already marketed device.