Fisher Wallace files citizen petition over FDA’s class III designation for CES

Fisher Wallace Laboratories of New York has filed a citizen’s petition with the U.S. FDA regarding the agency’s proposed class III designation for cranial electrotherapy stimulators (CES) for treatment of depression. The company argued that the agency disallowed evidence at an advisory hearing regarding this therapy provided by direct rather than alternating current, but also that the FDA had reneged on an earlier decision to classify these devices as class II devices.