I say yes it should be regulated by FDA as a Class 1 device at maximum. The reason I state this because when I was taking a class in Medicine and Literature a common theme was commercialization. With commercialization in the medical field, people have information quicker and go to doctors to ask for meds they think will help them because they saw it on t.v. So what I believe should take place is that it gets regulated by FDA as a Class 1 medical device, maximum and be sent to Doctors and EMTs i.e (medical profession and services) how to operate these devices. Also, for critical and life-threatening cases such as heart attacks and narcolepsy should be monitored by doctors so they get reasonable quantitive data that can be used to improve these Fitbit devices.