I agree that this system is fine as it is. I do not believe that more classes need to be created. As stated before this system runs entirely on risk and safety of the product. In the mini-sim the LAA closure device was considered as a class II because it is a heavily used product and its regards to safety are well known. The original question asks, “what if the company made an LAA device a little differently than the previously created versions, should it still be in class II”. I believe the answer to this would really depend on how different it was. If it was very different, than no, it will not remain as a class II device, and should instead be put into class III. The FDA does not need to create another type of classification for devices that have been developed before because many new devices use the previously created products to classify themselves. Making more classes would cause a lot of confusion, and does not seem very necessary.