Software as a Medical Device is the regulatory category covering standalone medical software. It is the framework under which nearly all authorized medical AI is reviewed, and it is what determines whether a product needs clearance at all.

Software embedded in and driving a hardware device is regulated as part of that device. Software analyzing images after acquisition, running on general computing hardware, is SaMD.

Where This Gets Misread

Whether a product is SaMD is a question about intended use, not about technical sophistication. A simple risk calculator making a diagnostic claim can be a device. A sophisticated language model drafting a note that a clinician reviews generally is not. Vendors are extremely aware of where that line sits, and product descriptions are written with it in mind.