FDA Reclassifies Electroconvulsive Therapy Devices to Lower Risk Category

The US Food and Drug Administration (FDA) recently published a final order requiring manufactures to file for a premarket approval application (PMA) for most uses of Electroconvulsive Therapy (ECT) Devices. This order also reclassifies ECT devices used in the treatment of catatonia or sever major depressive episode associated with major depressive disorder or bipolar disorder from a higher risk Class III designation to a moderate risk Class II designation.

However, the uses for ECT devices reclassified to Class II are limited to the treatment of patients age 13 years and older who are treatment-resistant, or who require a rapid response treatment due to the severity of their psychiatric or medical condition, with catatonia or severe major depressive episodes associated with major depressive disorder or bipolar disorder.

According to Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, “Today’s final order to regulate electroconvulsive therapy (ECT) devices in a way that appropriately reflects the known benefits and risks for specific indications for use provides patients with additional protections by requiring that manufacturers file the most rigorous application for marketing, a pre-market approval (PMA) application, to demonstrate safety and effectiveness for most uses and establishing new special controls that manufacturers must follow for other uses. This will give physicians more information on the safe and effective use of these devices and ultimately better protect patients.” The order went into effect December 26^th, 2018.

As a part of the 515 Program Initiative, ECT devices were one of two device types remaining to be classified. The order requires ECT manufactures, there are only two the FDA is aware of at this time, to file PMAs for all uses of ECT that are not being reclassified to class II, such as schizoaffective disorder and bipolar manic states, because as originally stated in their brief, “the FDA is unable to identify sufficient information to establish special controls to provide a reasonable assurance of safety and effectiveness of ECT devices for such indications.”

The FDA only mentioned major depressive disorder and bipolar disorder as they cited 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.” The order can be read in its entirety here.