Last year, the FDA suggested some ground rules: If you make an app that claims to diagnose or treat a medical condition, then you need to show that it’s safe and effective before you sell it, just as other medical-device makers do.
That seemed reasonable enough to the traditional medical-device industry, which is well-versed in the ways of the FDA. But the requirements — data on effectiveness, possibly clinical trials — have gobsmacked some software developers who are used to working in the fast-paced, relatively unregulated wilds of the Internet." Read more
