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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 require 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 safety 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 Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a statement. FDA regulates medical devices and categorizes them into one of three classes (I, II, or III) based on their level of risk and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.
For years, APA has strongly supported the reclassification of ECT devices as Class II. APA submitted formal comments to the FDA after the FDA proposed an administrative order for the reclassification in late 2015. APA cited numerous studies demonstrating evidence to support the safety and effectiveness of ECT for patients with treatment-resistant major depressive episodes. APA also encouraged members to submit comments to the Federal Register explaining the potential benefit of ECT reclassification. A similar effort was initiated years earlier when the FDA invited public comments on how ECT devices should be reclassified.
APA had also recommended the FDA designate ECT as Class II for use in mania in bipolar disorder, schizophrenia, and schizoaffective disorder, as well as for use in children and adolescents who meet the criteria for treatment resistance and who are in need of a potentially lifesaving intervention.
The reclassification of ECT devices is part of FDA’s 515 Program Initiative, which it began in 2009 to address some 26 devices that were issued “temporary” Class III designations some 40 years ago. ECT devices were one of the last two medical devices awaiting reclassification.
