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smk45 started the topic Fitbit Medical Device? in the forum Introduction to Project Management 7 years, 6 months ago
I came across an article that discusses whether or not Fitbits should be classified as a medical device as per new FDA guidelines. Since it is not 100% clear as to what the FDA will regulate, it hinders big tech companies such as Google or Apple from pursuing novel projects because to avoid any complications with the FDA. In the new draft FDA guidelines, they state that “software that analyzes multiple physiological signals (e.g., sweat, heart rate, eye movement, breathing—from FDA-regulated devices) to monitor whether a person is having a heart attack or narcolepsy episode” is a device subject to regulation. Under this statement, does that mean that Fitbits should be FDA regulated?