The FDA recently downgraded the cranial electrical stimulator (CES) devices designed to treat anxiety and insomnia from Class III to Class II, leaving CES devices for depression in the most highly regulated Class III category.
New CES devices intended to treat anxiety or insomnia will require 510(k) clearance rather than the more stringent premarket review (PMA). The agency published a final order placing CES devices for depression into Class III in 2016, and a proposed an order to reclassify the devices for anxiety and insomnia into Class II that same year.
“There is sufficient information to establish special controls to effectively mitigate the risks to health identified in section III, and … these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness when applied to CES devices intended to treat anxiety and/or insomnia,” the agency said in its recent final order.
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