FDA Lowers Risk Classification of Electroconvulsive Therapy Devices

The FDA has reclassified electroconvulsive therapy (ECT) devices that treat catatonia or severe major depressive episodes or bipolar disorder as moderate risk devices with special controls.

The agency moved the devices from Class III (high risk) to Class II (moderate risk) with special controls, noting that “sufficient information exists to establish special controls that mitigate known risks and provide a reasonable assurance of safety and effectiveness for these two uses of ECT devices.”

ECT manufacturers must file a premarket approval application for all uses that haven’t been reclassified to Class II, such as bipolar manic states and schizoaffective disorder.

The FDA previously published a proposed order to reclassify the devices in December 2015 and received over 3,400 comments from industry, professional organizations, trade groups and individual consumers, many of which generally supported the reclassification.

Other comments said the proposed reclassification didn’t go far enough and called for an expansion to include other indications, such as autism, Parkinson’s disease, schizophrenia, mania and delirium, among others.

The FDA said it “concluded that there was insufficient scientific evidence to support reclassification” for the other indications discussed in public comments.