I am going to keep Fitbit out of this discussion since it is already being classified as a class 2 device. That being said, I do not think companies can control how their product is utilized once it is sold. Yes, they are obligated to market the product correctly. And if the company tags it with “general wellness” and not for medical diagnostic purposes, I do not think the company would be liable for device’s usage. Also, these devices are not accurate enough to be considered as a medical device that can be used for diagnostics purposes. Yes, intended use is the same as the medical devices, to monitor health parameters. However, there are already more accurate, and regulated products in the market. Another factor could be a cost of the product after it is regulated. If these devices start getting regulated, it would certainly raise the production cost as well as consumer cost.
Similarly, if the scotch tape is being used as a bandage and ripping users skin, your company is certainly not responsible for that injury. However, if the product label is misleading, I believe your company will certainly be liable. The “line” between intended and actual use is very thin and how the consumer uses the product is entirely up to them. They certainly paid for it. However, companies, in my opinion, are obligated to market the product for its intended use and not the “assumed” use.

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.

Replying to Amin's post on the intended use of Medical devices. I believe the company developing the device should do their due diligence in determining potential adverse effects of how their device is interpreted and used. A company should be responsible for the "assumed" use in this case if a majority of patients have been found to misuse their device and cause harm in an accidental manner. Where the patient is genuinely trying to operate the medical device in a manner in which he/she believes it is intended to be used. If this does ultimately pose harm to a large patient population, that indicates a major systemic gap in their design itself, potentially the user interface, or overall instructions for use. There are ways to avoid issues like this.This can be done through a variety of methods such as tamper proofing the device or something like a one time use syringe that can be inoperable after one use. The instructions should specifically detail how the device should be used and leaves less for the end user to interpret and formulate their own method of use. Labeling and instructions for use and the less ambiguity you provide for the end user the better for a medical device.

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.