26/09/2022.
It is not clear the allocation in U.S.A. of Clinical Decision Support systems into the category of SaMD (software as medical device).
The Section 3060 of the 21st Century Cures Act excludes from the definition of “medical device” a Clinical Decision Support SW where the system enables medical professional to independently review the basis for the provided recommendation and he/she does not rely on any of such recommendations as the exclusive tool used to make a clinical diagnosis or treatment decision”.
Keep reading at Medical Regulations in USA for software and artificial intelligence.