FDA Final Order: Neurological Devices; Reclassification Of Electroconvulsive Therapy Devices; Effective Date Of Requirement For Premarket Approval For Electroconvulsive Therapy Devices For Certain Specified Intended Uses

This document was released on December 26, 2018, by the U.S. Food and Drug Adminstration (FDA). It presents the FDA's decision to reclassify devices used to provide electroconvulsive therapy (ECT) to consumers with certain conditions that have been well. The FDA reclassified ECT devices from the current Class III to the lower risk Class II when the device is used for ECT to treat catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in individuals age 13 years and older who are treatment-resistant or who require a rapid . . .