FDA Withdraws PMA Plan For Cranial Electrotherapy Stimulators
This article was originally published in The Gray Sheet
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.
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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’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.
With price controls in Medicare looming nine years after approval, launch strategies such as ‘bridge’ programs that build initial volume with free drug may have to be adjusted.