Control mechanism

FDA lists a change in control mechanism as a change that may need a new 510(k). Moving from hardware to software control is a common example.

The manner by which the actions of a device are directed. An example of a change in control mechanism would be the replacement of an electromechanical control with a microprocessor control.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology