Cranial Stimulators Split By FDA Into Class III For Depression And Class II For Anxiety/Insomnia
This article was originally published in The Gray Sheet
Executive Summary
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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