Non-device CDS

Section 520(o)(1)(E) of the FD&C Act excludes certain CDS from the device definition when all four criteria are met, including that the professional can independently review the basis for the recommendation. Software that analyzes medical images or signals, or that is meant to replace clinical judgment, stays a device.

decision support software functions that do not meet the definition of device in section 201(h) of the FD&C Act.

FDA guidance: Clinical Decision Support Software (January 2026), Section I, Introduction