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www.fdanews.com/articles/145553-devicemakers-fda-manipulated-panel-to-keep-depression-therapy-in-class-iii

Devicemakers: FDA Manipulated Panel to Keep Depression Therapy in Class III

April 11, 2012
Makers of cranial electrotherapy stimulators (CES) are crying foul in the wake of an FDA advisory panel meeting that ruled against reclassifying the devices. But the FDA says it did nothing wrong. CES is used to treat depression, anxiety and insomnia by delivering a mild electrical current through the brain. In August, the FDA published a proposed rule mandating CES makers file PMAs for their products, which were grandfathered in under the 1976 device amendments. Electromedical Products International (EPI), Fisher Wallace and Neuro-Fitness filed petitions to move the devices to Class II.
Devices & Diagnostics Letter