Clinical Decision Support Software
Also called: CDS, CDSS
Software providing clinicians with information or recommendations to inform a decision, some of which is regulated as a device and some of which is not.
Clinical decision support spans drug interaction alerts, risk calculators, diagnostic suggestion tools, and treatment recommendation systems. Whether a given system is a regulated device depends on the basis for the recommendation and whether the clinician can independently review it.
Broadly, software that explains its reasoning well enough for a clinician to evaluate it independently, and that does not drive a time-critical decision, falls outside device regulation.
Where This Gets Misread
That exemption rests on the clinician actually performing an independent review, and decades of alert fatigue research show what happens to review under load. The regulatory logic assumes a behavior that deployment conditions systematically erode.