I agree with the posts above that fitbit should not be classified as a medical grade device because it’s purpose is not to be used as a replacement for an EKG. The purpose of fitbit and similar activity bands is to give a general guidance on your daily activity and not exact measurement. If it were to be considered a medical grade device it would most likely require a 510(k) since there are similar health monitoring devices out on the market currently that it can be comparable to. I saw an interesting article on a similar dilemma that the apple watch also had when it first came out back in 2015. The main reasoning that was given back then is that the FDA cycles are to long for products to release for these companies which was an interesting point, since 510(k) would create a shorter vetting process for devices such as fitbit and the apple watch. Any thoughts/responses to the cycle being to long holding back innovation?

Link to article: http://bgr.com/2015/11/10/apple-watch-fda-medical-product/