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  • andria93 replied to the topic Fitbit Medical Device? in the forum Introduction to Project Management 7 years, 4 months ago

    I think the Fitbit should be classified as a class 1 device. some of this devices still had sensors to collect health-related information such as; heart rate and blood pressure. Which full under general control. But, I think they classified it as Class 2 due to Software involve in this type of calculation. The first department for such a project should be CDRH as it can be a medical device. Marketing for such devices heavily relay on improving health and motivate people to exercise more under the supervision of this devices calculation.