The International Medical Device Regulators Forum has developed guidance outlining the steps required to generate clinical evidence of effectiveness and safety of software as a medical device (SaMD).
The draft guidance, issued by the FDA for public comment, addresses stand-alone software designed to produce or extract data, including diagnostic information, in tandem with a medical device. SaMD is not part of a device, nor is it used to operate a device, and would run on general-purpose computing platforms.
The first step in generating evidence would be to determine whether the scientific validity of the SaMD is already well-known. If not, scientific validity evidence would need to be generated. — Jim Stimson