Risk Classification And The Device-Benefit Question: Cranial Electrotherapy Stimulators
This article was originally published in The Gray Sheet
Executive Summary
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.
You may also be interested in...
FDA Issues Split Classification On Cranial Electrotherapy Stimulator Devices
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.
Electroconvulsive Therapy Devices: FDA Proposes 510(k), Special Controls
FDA is proposing to reclassify electroconvulsive therapy devices aimed at treating major depressive disorder to class II with special controls, but require PMAs for other indications. The proposal does not align with a 2011 FDA panel recommendation to keep ECTs for depression in the class III category and require PMAs.
Panel Recommends PMAs For Cranial Electrotherapy Stimulators
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: