FDA: Downclassify medical devices that don't satisfy the definition of Class III.

The Food and Drug Administration is required to classify medical devices into one of three classes. Due to a logical flaw in Form FDA 3429 that existed until July, 2012, certain devices were directed into Class III despite the fact that they don't satisfy the definition of Class III in the law. So far, FDA has failed to acknowledge this problem, which imposes a heavy burden on the makers of such devices.