Due to an error and not being able to make a new forum I am posting here. While the topic is related to Fitbit, the question is not the same.

Should how we use a device define it?

When determining whether a device requires FDA approval, should the common use/assumed use of the device by consumers be put into consideration? If not, should the company be responsible for reasonable interpreted/implied/assumed functions of a device i.e. How it is marketed?
Since the device is marketed as a health monitoring system, and promotes physical activity and is used as a marker/ tracker during those activities, should the device be classified as a medical device even though it’s quote unquote intended use is not for diagnostic purposes but only for general wellness. While Fitbit is now a class II device, what about other devices that are used for medical purposes without clearance?

To put this into perspective, if my company, “Medical Grade”, manufactured regular scotch tape intended to be used as regular tape, but the product is mainly used in conjunction with cotton swabs to make homemade bandages, should my company have any responsibility should the tape rip someone’s skin off or cause a rash? (note the product is labeled the same way as all other similar products on the market)
Should it be tested the way medical devices similar to it are tested? Where does the line between intended use and actual use fall (if you believe that wall even exists)? I believe that the company must alter it labeling to clear specify that its intended use is NOT the assumed use and that labeling should also reflect the actual use of the product even if government labeling regulations don’t require it currently.