I believe that the system is okay as is. I believe the ability to approve medical devices based on predicate devices speeds up the process of approving necessary devices for the population. This is a bit of a different example but for rare diseases know as orphan diseases, which only affects a small percentage of the population the FDA offers the ability to expedite the process because there might not be many treatments out there for these diseases. While I agree with your point that the difference between the proposed device and the predicate device might be significant, the FDA determines the risk. If they see that the risk is greater and creates a significant difference from the predicate device then they would classify as a class III.