Zdrowie i gospodarka · 29/12/2015

FDA Proposes Reclassification of Electroconvulsive Therapy Devices for Treating Severe Major Depressive Episodes

The US Food and Drug Administration (FDA) is proposing to reclassify electroconvulsive therapy (ECT) devices for treating severe major depressive episodes in adults aged 18 and older who are treatment-resistant or require rapid response due to severe psychiatric or medical conditions, from Class III to Class II, requiring premarket approval applications or product development protocols for other intended uses.