It is not in the best interest of any company to try to deceive or commit fraud in classifying their device as it taints all future submissions to the FDA if they are even allowed to continue operating. Additionally it raises many ethical concerns regarding their decision making and in my opinion safety concerns of all their other products already on the market. Medical Device companies should remain grounded in their duty to the general public, the people that will be using these devices and who have faith that their device will provide them a better quality of life. If the misclassified device makes it to the market and starts causing problems, the company could be faced with serious repercussions depending on the severity of the problems.

I don’t have much experience with any of this as I’m still an undergrad, but is it at all possible to accidentally misclassify a device and the FDA approving it? If the FDA realizes their mistake what would happen to the company? Not sure if this has ever happened before.