Based on the intended purpose of the Fitbit I do believe that it should undergo FDA regulations. The purpose of the Fitbit is to monitor an individual’s heart rate, which can become a very serious issue for individuals’ who are suffering from heart problems. Although the Fitbit does not say it is meant to monitor an individual’s overall health and improve an individual’s daily life it is supposed to monitor well being. Health products are not something that is supposed to work most of the time. Even though not everyone needs the Fitbit for serious issues, some individual’s do and now they are being put at risk by faulty products. Based on the market for wearable devices that can monitor health, the Fitbit is extremely popular meaning that more people are using it and that more people will be relying on. Testing must be done on all medical devices, even those that have small intended purposes to ensure accuracy and reliability for the user.
If the device were to be regulated by the FDA it would be under the CDRH and it would be labeled as a class 2. It is a device that is based off of other heart rate monitoring devices and it has previous devices, so therefore it can not be a class 3. Although it possess a risk, that risk is only directed at a small select group of people who rely on it, but it is not life supporting as individuals can live without wearing the device. This device enhances life if used properly, but with poor readings, the device can misguide individuals and can pose a serious risk.