To be honest, I think they have to do both things to get regulated under the FDA. The FDA is involved because they consider it a "device" that is "intended for

To be honest, I think they have to do both things to get regulated under the FDA. The FDA is involved because they consider it a "device" that is "intended for use in the diagnosis of disease or other conditions." If they just did the analysis based on provided data, I don't think that would count as a device.