Software as a Medical Device (SaMD)
Also known as: SaMD, FDA regulated health software, AI medical device
Software intended to perform a medical purpose, such as diagnosis, treatment, prevention or prediction, without being part of a hardware medical device, which brings it inside FDA device authorities.
Software as a Medical Device is the classification that determines whether a healthcare AI tool is regulated by the FDA, and it turns on function rather than marketing language. Software that diagnoses, treats, predicts, or drives a clinical recommendation generally falls inside the definition; software supporting administrative work or drafting documentation for clinician review generally does not. The practical consequence is that a tool can change regulatory posture through ordinary product development, for example when a documentation product adds diagnostic coding suggestions. Clearances are also specific: an authorization covering one finding on one imaging modality is not validation for everything adjacent to it, which makes matching the exact clearance to the exact intended use a necessary review step.