Software as a Medical Device
Also known as: SaMD
Software intended to be used for a medical purpose that performs that purpose without being part of a hardware medical device.
Software as a Medical Device is an international term for software whose intended use is itself medical: diagnosis, treatment, prevention, or mitigation of disease, delivered by software rather than by hardware it controls.
The classification turns on intended use rather than on technology. The same underlying capability can fall inside or outside the definition depending on the claim the manufacturer makes about it.
This distinction is the reason two products that look similar to a clinician can face completely different regulatory expectations. It is also the reason vendor marketing language is drafted so carefully in this category.
Nothing in this entry establishes the regulatory status of any product. Whether a specific tool is regulated, and under what authorization, must be verified directly against the applicable regulatory record.