What a loud of BS.
“class II device Regulatory affairs A ‘medium risk’ medical device–eg, hearing aids, syringes, approved by the FDA for use in humans. “
But on the outher hand this may be something we should be very worried about.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072191.pdf