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
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.
You may also be interested in...
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.
In the final medical device electromagnetic compatibility guidance FDA clarified the scope of applications that could use this guidance and added a recommendation for sponsors to identify and consider the intended use environmental that could affect the EMC of their products.
CDRH withdrew a prior proposal to require PMAs and class III risk-status for cranial electrotherapy stimulators, and now says it plans to downclassify the devices into class II, with special controls.