The FDA is currently drafting a guidance to regulate certain “general wellness devices.” These include ones that help “log, track, or trend exercise activity” for the maintenance of a healthy lifestyle, exactly what the Fitbit does. Although, with the coercion of top med-tech companies, this guidance is very relaxed and not strictly enforced. Probably for the reasons outlined in all the posts above. That is, its not a definition medical device and its more low risk than a “low risk product.” However, I feel that the FDA should regulate the Fitbit for the simple reason that it is a lot more than a mood ring. Even though it is strategically marketed as an inconsequential, fun gadget, people take it seriously and incorporate it into their routine. Buying one is letting everyone know you’re serious about being healthy. This is the reason they sell; pretending they are not impactful enough to merit regulation is wrong and unfair to the consumer. I agree with several earlier posts that Fitbit should be a Class I product.

Guidelines:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429674.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery