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  • hc255 replied to the topic Fitbit: A Medical-Grade Device? in the forum Introduction to Project Management 7 years, 4 months ago

    Since the FDA sees the Fitbit as a nonregulated device then it will stay as such. If the FDA considered the Fitbit as a medical device then regulations would need to be in place. Given that the device is a consumer health device, the FDA does not want to impose regulations. I personally believe that the FDA should step in to regulate this and other related devices because of the implications that exist with user experiences. However, I believe that the doctor should not have recommended the device to the patient given his history. Legitimate devices should be used to track heart rate especially if one has a condition.