I was just popping in to post essentially the same thing. I have worked on two class III medical devices (systems work with a focus on software) over the past

I was just popping in to post essentially the same thing. I have worked on two class III medical devices (systems work with a focus on software) over the past eight years (lead developer and project manager). It is obvious to anyone who has an ounce of experience dealing with the FDA that the interpretation is the problem and that such a product should be regulated in some way. Honestly, their comments come off as a bit flippant, and really, they should be a bit more fearful. Right or wrong, the FDA is not to be trifled with.