Other function

FDA does not review the other function itself, but it may consider how the other function affects the device function under review. Manufacturers should assess and document that impact in the submission.

function that: • does not meet the definition of device; • meets the definition of device, but is not subject to premarket review (e.g., 510(k)-exempt); or • meets the definition of device, but for which FDA has expressed its intention not to enforce compliance with applicable regulatory controls.

FDA guidance: Multiple Function Device Products: Policy and Considerations (July 2020), Section III, Scope (terms used for the purposes of this guidance)