Do hospitals need FDA clearance to use AI software?

Whether FDA clearance is required depends on how the software is classified and marketed. Software that meets the FDA's definition of a medical device, generally because it is intended to diagnose, treat, or otherwise directly inform a clinical decision, typically needs clearance or another applicable regulatory pathway before it can be marketed for that use in the U.S. Software used purely for administrative or operational purposes, such as scheduling, is usually outside that requirement. See Software as a Medical Device (SaMD).