This is kind of a note to myself and thinking out loud that wanted to share. I’ve been thinking a lot about the certification of the OFM as a medical device. I realized that this is an identical situation to the Philips IntelliSite Pathology Solution. So far, this is the ONLY FDA approved imaging device that can be used for diagnosis. The good news is that Phillips efforts has facilitated the FDA certification process for everyone else.
There are other certification processes that pertain to manufacturing.
Please feel free to comment!