(2009-03-11) Fda May Regulate Mobile

The FDA may attempt to regulate Mobile devices like the IPhone as Medical Device-s (HealthCare). "So an MRI app for an iPhone is a wireless medical device? Or a patient reporting their blood glucose level by text messaging their physician who then adjusts their insulin dosage with a return SMS?" According to MHN, DonWitters initially responded that he thought these examples constituted information exchange, which would be different. But he then backpedaled and indicated that the FDA could consider iPhones to be wireless medical devices.


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