USA – FDA Reclassifies Some ECT Devices

Electroconvulsive therapy (ECT) devices used for the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder have been reclassified from Class III (higher risk) to Class II (moderate risk) with special controls.

“The safe use of ECT for treatment of these conditions has been well studied and is better understood than other uses,” FDA said in making the decision. “Therefore, 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.”…