FDA Issues Split Classification On Cranial Electrotherapy Stimulator Devices
Devices Placed In Class II to Treat Insomnia and Anxiety, Class III for Depression
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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Companies are suspicious of FDA motivations in the drawn-out reclassification process for cranial electrotherapy stimulators. But the case also underscores how the agency's efforts to place devices in the appropriate risk category turns not only on the perceived safety of a device, but evidence supporting its benefits and the types of evidence the agency is comfortable accepting.
In a Jan. 21 proposed order, FDA says it wants cranial electrotherapy stimulators to be split into two classifications: those intended to treat insomnia or anxiety into class II, special controls, and those intended to treat depression into class III, requiring a PMA.
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