"Even though your device is labeled RU[O], you are labeling it and promoting it for nonresearch clinical diagnosis without clearance or approval in violation of the Act. ... These statements suggest the clinical utility of the device and instruct clinicians on the use of this device to detect and diagnose disease. ... These are diagnostic claims that indicate that the device is intended for clinical in vitro diagnostic use, and not for research use only."
— FDA Warning Letter, 9/14/11
I could be wrong, but I think this warning letter might be the first one issued under the rubric of the recent RUO draft guidance. Whether it is the first or not, one thing is clear: the gauntlet has been thrown.
I don't know any more about this specific case than what's posted online. I think it's safe to say we're going to be advising some of our clients to take another look at their risk assessments.