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FDA Issues Split Classification On Cranial Electrotherapy Stimulator Devices

Devices Placed In Class II to Treat Insomnia and Anxiety, Class III for Depression

Executive Summary

The FDA has moved to finalize a proposed order that would allow cranial electrotherapy stimulator (CES) devices to be marketed via the 510(k) pathway to treat insomnia and anxiety but mandates PMAs for depression indications.

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