I agree with what has been stated before me. I do not think the Fitbit should be considered for FDA approval; as it does not make any medical claim. This function of the watch is merely there for convenience and for those trying to get a general idea of what their current lifestyle is, and how they can change it to reach a goal. One should not consider on a heart monitor worn on the wrist as medical grade as it’s not that reliable of a location. Listening to the chest or getting a pulse from the neck is a more reliable way. It would be interesting to see Fitbits worn as a necklace to get a more accurate reading, but that takes away the convenience of looking at it while wearing it. At that point you might as well just wear a standard, under the shirt heart monitor.
You would think people would read the fine print of the product to see/realize this is not a medical device that doctors say to use. If doctors did want to recommend the product for official use, the Fitbit would have to get class 1 approval.