A company plans a major change to the fundamental scientific technology of its device. How should this change be filed?

In the context of regulatory submissions for medical devices, when a company plans a major change to the fundamental scientific technology of its device, the appropriate pathway would generally be to file a Traditional 510(k). This submission type is designed for devices that have undergone significant changes, which might include modifications to the fundamental design, materials, or technology that could affect safety and effectiveness.

The Traditional 510(k) process requires comprehensive data and documentation to demonstrate that the modified device is safe and effective. This is necessary because significant technological changes often require a deeper evaluation compared to modifications covered by other submission types.

In contrast, the Special 510(k) is typically used for devices undergoing minor changes that do not alter the fundamental scientific technology or intended use, allowing for a streamlined review process. An Abbreviated 510(k) is utilized when the applicant can rely on existing guidance documents or consensus standards to demonstrate substantial equivalence. A PMA (Premarket Approval) is needed for high-risk devices requiring more extensive clinical evidence, which is not the scenario here.

Given the significant nature of the change to the device's fundamental technology, the Traditional 510(k) submission is the adequate regulatory pathway to ensure that the device remains compliant and safe for market use.