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Cranial Electrotherapy Devices into Class 2


Federal Register Proposed order: FDA proposes an administrative order to reclassify the cranial electrotherapy stimulator (CES) device intended to treat insomnia and/or anxiety, a preamendments Class 3 device, into Class 2 (special controls). The devices would be subject to premarket notification and FDA would require the filing of a PMA for CES devices intended to treat depression. This action is based on new information pertaining to the device. FDA is also clarifying the identification for CES devices in this proposed order by identifying CES as a prescription device that applies electrical current that is not intended to induce a seizure to a patient’s head to treat psychiatric conditions. This clarification distinguishes CES from electroconvulsive therapy. To view this proposed order, click here.