I strongly agree with RyanRattazzi’s point about adding more tiers to the medical device classification system: it would be an unhelpful and unneccesesary addition to add something like a class IV device. From a risk indication perspective, Class III devices already indicate that the device presents the most risk for harm. To add a Class IV would not make sense: either you say it presents the “most, MOST” amount of risk (sounds a little silly right?) or you would make Class IV the most and reclassify the other three Classes to other degrees of risk. Reclassifying the classes like that would cause even more confusion around device classifcation than there already exists and would likely serve to create more harm than good. However, more description about the existing classes on what the criteria may help instead. In addition, a great addition to these classifications would be some kind of qualification standard for combination products, where MD manufacturers can have a pretty close idea of what jurisdiction of the FDA their combo product will land and what legwork they will need to do.