I work in regulatory affairs for a medical device company doing risk management and mitigation for FDA submissions regarding class II, III and combination devices... review the FDA guidance on medical device classifications, including their guidance on classifying low-risk “general wellness” devices. If FitBit, or any…

What would the point be of having some kind of wearable that measures the functions required by an electroencephalogram? Any reason to need a map of your brain would definitely be a high risk medical device to place in the hands of a consumer?

That is extremely risky and would throw the FitBit into a higher medical device category, for blood pressure, sugar levels and electroencephalographic measures. From a FDA regulatory perspective, I couldn’t see any large companies trying to delve into this direction just yet. It also would not be approved by the FDA…