Panel Recommends PMAs For Cranial Electrotherapy Stimulators
This article was originally published in The Gray Sheet
FDA’s Neurological Devices panel recommends that pre-amendment cranial electrotherapy stimulator devices should remain in class III, with PMA requirements, due to a lack of efficacy data.
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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.
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.