You know what, I had a look and can't actually find it now. Maybe I'm getting my wires crossed. For some reason I believed that due to their clinical validation the FDA process was relaxed but going back and re-reading some of their announcements I'm not so sure. Either way I will edit my first post to stop giving anyone the wrong idea.
I did however find this from a recent update which kinda validates some of my original point.
You know what, I had a look and can't actually find it now....
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