Richard H Epstein - Comment

Does the FDA intend this guidance to apply to hospitals creating applications on mobile devices or accessible via mobile devices from hospital servers such as calculators (e.g., BMI, GFR, BSA, weight and/or time based drug doses) where the software 1) is only available to employees of the institution; 2) was developed solely for internal use and 3) is not intended for sale or distribution via interstate commerce? Does it matter if the application is accessible to employees from physical locations across state lines through a secure portal or VPN? The potential for errors for manual calculation of these derived quantities is considerable and almost always will require the indivdiual to manually enter the values into an electronic calculator. I would ask the FDA to balance the risk of such uncontrollable user errors against the benefits of letting the computer do the math.