FDA Downgrades Risk Category for Certain Uses of ECT

The Food and Drug Administration (FDA) issued afinal order on Wednesday to downgrade the risk category for certain uses of electroconvulsive therapy (ECT).This was a change for which APA had strongly advocated, saying it could greatly expand access to safe, effective treatment for individuals with serious and persistent psychiatric disorders.First, the FDA ’s final order reclassified ECT devices from Class III (higher risk) to Class II (moderate risk) for the treatment of catatonia or a severe major depressive episode associated with major depressive or bipolar disorder. The order applies to ECT use in patients who are treatment-resistant or who req uire a rapid response due to the severity of their condition.In addition, the FDA lowered the minimum age for whom these ECT devices are considered Class II products to 13 years, from its originally proposed 18 years of age.Finally, the order requires ECT manufacturers to file FDA ’s most rigorous application for marketing known as a premarket approval (PMA) application for all other uses of ECT devices, such as for schizoaffective disorder and bipolar manic states. The agency notes that this is because the FDA is unable to identify sufficient information to ensure the safe ty and effectiveness of ECT for such indications.“This will give physicians more information on the safe and effective use of these devices and ultimately better protect patients,” said Carlos Peña, Ph.D., director of the Division of Neurological and P...
Source: Psychiatr News - Category: Psychiatry Tags: APA Class II Class III ECT electroconvulsive therapy FDA Federal Register major depressive episode reclassification treatment-resistant depression Source Type: research