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.
The FDA said it will also create a new product code for CES devices for anxiety and insomnia.
The agency considered downgrading the depression-treating CES devices as well, but found the evidence supporting their effectiveness was the weakest. It keeps a device in class III if insufficient information exists to determine that general controls and/or special controls can provide reasonable assurance of its safety and effectiveness. Although there were few adverse event reports filed regarding CES devices used to treat depression, one of them said the patient suffered a third-degree burn, the agency noted.
The FDA also will continue to require sponsors of CES devices for anxiety and insomnia to produce clinical data showing meaningful results in addition to safety. It will not enforce compliance with special controls to manage risks posed by currently legally marketed CES devices intended to treat anxiety and/or insomnia until one year after the effective date of the final order.
The final order went into effect Dec. 20, 2019.
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