The FDA classification system seems fine for the most part. There have been previous issues with the “predicate device” exemption when companies try to base this off something that was developed more than 15 years ago. Technology has improved so much in that time that it is hard to compare new products to such seemingly archaic products. But besides this, class II devices still need to provide sufficient clinical data to verify its safety and efficacy but helps it get to market faster without the barriers and stipulations of class III. While class III is certainly for high risk products, another key feature is that is a novel idea. This means something like it has never been done before so the risk profile is generally unclear. I think there are more benefits with comparing to predicate devices in terms of making it easier for devices to get approved than there are unsafe products slipping through using this loophole.