FDA proposes to require PMAs for cranial electrotherapy stimulators for depression

The FDA is proposing to require manufacturers of cranial electrotherapy stimulators to submit pre-market approval applications if their devices are intended to treat depression.

The federal safety watchdog said it’s also proposing to down-classify CES devices aimed at treating insomnia and anxiety from Class III, which would also require PMA applications, to Class II subject to premarket notification.

Stakeholders have until April 21 to comment on the proposals, the FDA said.

Devices would fall under the new requirements include the CES Ultra made by Neuro-Fitness; the Alpha-Stim made by Electromedical Products International; and the Fisher-Wallace Stimulator.

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