FDA Reclassifies Electrotherapies for Anxiety and Insomnia

December 27, 2019

The FDA issued a final order reclassifying class III cranial electrotherapy stimulator (CES) devices for treating anxiety and insomnia as class II.

The class II status means that CES devices intended to treat anxiety and insomnia will now be subject to special controls. For example, components that touch the patient must be shown to be biocompatible, and sponsors must test their devices for electromagnetic compatibility in areas of intended use.

The agency also requires premarket approval applications for CES devices intended to treat depression.

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