@Scott, I will definitely give it a read. My understanding, albeit might be wrong, was if the device is used for monitoring (at least in the glucose monitoring space) it is class 2. If the device is used for screening or diagnosis, it is Class 1. All related to risk, and makes complete sense to me. A bad glucose monitor can lead to poor insulin management which has long and protracted ramifications.
That beings said, I am anxious to further clarify the line in the sand as it defines potential to-market strategies and the capital required to achieve them.