Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode

This reclassification will make it easier to use and manufacture ECT devices. People with ECT experience should tell their stories as part of the public response to this proposed reclassification.....
https://goo.gl/Pv4AHu

The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the electroconvulsive therapy (ECT) device for use in treating severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls) based on new information