During this weeks “Mini-Sim” we were asked to select a product and decide the classification and regulatory pathway for the device. When I selected “Stop-Gap”, the Left-Atrial Appendage Closure Device, it seemed to make sense that this would be a Class 3 device. However, I was soon informed that it was actually a class 2 device because prior companies have developed and sold LAA Closure devices, and therefore the risk profile of the device is well understood. But what if this proposed company is making the LAA Closure device differently resulting in a less safe device? Because another company has previously manufactured the same technology does not seem to me to be enough reason to lower the regulatory class of the device. As this becomes a more common occurrence, do you think there should be a separate classification for devices that have been developed before? Or is the system fine as is?