I am into my 3rd day at a conference hosted by CONTINUA and CIMIT on medical device interoperability at the FDA. We are engaged in a 3 day communication, interaction, workshop on how to apply the existing 510(k), 513(g), IDE rules and processes to interoperable medical devices and those applications that fall into the domain of interoperability. This is a rather unique area as attributes that are affected are intended use, risks and hazard assessments. I am unsure as to outcome as of yet, but it is clear that a key purpose of the conference has been achieved: getting device manufacturers, EMR vendors, and the FDA in the same room to discuss the intended purpose. If nothing else, this is truly a feat.
