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

When a company is planning a significant change to the fundamental scientific technology of its device, the most appropriate filing would be an Abbreviated 510(k). This is because an Abbreviated 510(k) is utilized when there are modifications that do not alter the intended use or fundamental technology but may impact certain characteristics of the device. It allows for a streamlined approach, where the same scientific principles can ensure safety and effectiveness.

In the context of a major change, it's important to recognize that while the Abbreviated 510(k) is a quicker pathway, it’s specifically structured for changes that have been previously validated through performance data. It requires less documentation than a Traditional 510(k) but still necessitates adequate support and justification for the modification.

Choosing a Traditional 510(k) would be inappropriate for significant technological changes because it typically covers modifications that do not alter the fundamental device unchanged and require a full assessment. Meanwhile, a Special 510(k) applies to minor changes, such as changes to the design or manufacturing process but not significant technology shifts. A PMA (PreMarket Approval) is reserved for devices that are classified as Class III and necessitate rigorous clinical evidence for approval, which is not pertinent to this scenario involving a significant change