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Cranial Stimulators Split By FDA Into Class III For Depression And Class II For Anxiety/Insomnia

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.

FDA would reclassify cranial electrotherapy stimulators (CES) into two separate classes, placing those intended to treat insomnia and anxiety into class II, with special controls to mitigate risks, and those designed to treat depression into class III requiring a PMA, under a proposed order

released Jan. 21.

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