The U.S. FDA has proposed to down-classify optical diagnostic devices and electrical impedance spectrometers from class III to class II, but there was little support for such a change in the first day of a two-day advisory hearing. The panelists saw the risk of a false negative for melanoma as too high to allow such devices to go through the 510(k) program, and thus manufacturers of these devices may continue to be required to file PMAs, replete with costly studies and long timelines to approval.