News Report | January 13, 2019
FDA Reclassifies Electroconvulsive Therapy Devices To Lower Risk Class For Some Uses
On December 26, 2018, the U.S. Food and Drug Administration (FDA) issued a final order to reclassify electroconvulsive therapy (ECT) devices to a lower-risk level. The new classification applies only 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 response due to the severity of their psychiatric or medical condition. The FDA said the safe use of ECT as treatment for catatonia or MDE . . .