Comment: Re:We no longer regulate ads and mail order produc (Score 1) 254
I would refer back then to what the FDA considers an app. I'm not referring to documentation, but something that is performing an action (e.g a measurement). The FDA will ultimately be the arbiter, so if you are in the medical device industry (as I am) you would be wise to accept that guidance and consult with your legal and compliance teams.
Ask Pfizer exactly how much the government likes coming after violators.