I can only hope the FDA knows the difference between computer hardware and software. Surely their apparent lumping of apps with hardware devices most stem from anomalies in legislation or failure to keep up with reality.
Even when I first learned to program in Fortran on the IBM 360 at NASA Langley Research Center 50 years ago -- you know, the one in Hidden Figures -- everyone exposed to computers seemed to understand the difference between hardware (devices) and software (programs or applications). Did our lawmakers somehow miss that boat? Or was it the bureaucrats? (I know! Assigning blame will not fix the problem.)
What if the device, in many cases today a mobile phone, meets the criteria for "safe and effective" but the app that runs on it fails, or vice versa? Should FDA, or other more appropriate agency, not assess them separately and apply different criteria?
I thought the "D" in FDA stood for "drug" anyway, but if the bureaucracy must handle devices and apps, too, at least keep them in separate categories.
I promise you Behavenet will do.