I think we can all agree that the classification comes from the risk and novelty of the device. However when preparing my response for another forum post, I learned that this classification system was made back in 1976. And according to the link – https://www.fda.gov/MedicalDevices/NewsEvents/News/default.htm – there have been very little updates to the classification system, even some recalls on a class 1 device.
I thin a better question to ask would be “should the classification system be changed/updated/modified to include more modern problems?”
Going off of my new question, I would say yes. I think they need to stricter regulation on their products to include modern day technology and advancements.