@f-dot, I agree that the FDA does have to stay on top of modern day devices applications, but don’t think modern day technologies need a different classification system. I think it is still useful to a classification system based on risk, Class I, Class II, and Class III devices. I think they could maybe include more guidance documents regarding more modern devices, but I think it makes sense for them to still be classified into a Class I, II, or III device. Were you thinking they would add a Class IV device or how would you envision a new modern classification system? Would adding more classes make it more complicated, would it be based on risk or something else?