Fitbit is a consumer product that has the intention of tracking one’s daily fitness, heart rate, and blood pressure. However, there are people who filed a lawsuit against this company. The plaintiff David Urban bought a Fitbit PurePulse Tracker to monitor his heart rate while training for the marathon. Since Urban had a family history of heart disease, his doctor recommended the Fitbit to monitor his heart rate at home. However, Urban claims that the Fitbit under-recorded his pulse by much as 25 bpm. According to Dr. Vincent Pedre, a physician who practices internal medicine says “if users with cardiovascular diseases rely on a device that under-reports their heart rates, then the user could exercise at a level that puts stress on the organ, potentially leading to a heart attack.” CEO James Park says that Fitbit is not a medical-grade device, but a consumer device. The FDA opted to not regulate what it calls “general wellness devices”.

Therefore, should “general wellness device” such as the Fitbit undergo FDA regulations, since it can affect one’s health if device reading is wrong? Why or why not?
If the “general wellness device” does go through FDA approval, what class would Fitbit fall under? Why?

Reference
https://www.bloomberg.com/news/articles/2016-04-15/fitbit-s-move-into-medical-gadgets-risks-attracting-fda-scrutiny