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Medical Devices / Regulatory Affairs

FDA Lowers Risk Classification of Certain Electroconvulsive Therapy Devices

Dec. 28, 2018

The FDA has reclassified electroconvulsive therapy (ECT) devices for treating 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 “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 PMA for all uses that haven’t been reclassified to Class II, such as bipolar manic states and schizoaffective disorder. The agency cited a lack of adequate information for establishing special controls for such uses.

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