December 21, 2018
“Providing patients with serious mental health conditions access to reasonably safe and effective medical devices that meet their health care needs remains a priority for the FDA. Today’s final order to regulate electroconvulsive therapy (ECT) devices in a way that appropriately reflects the known benefits and risks for specific indications for use provides patients with additional protections by requiring that manufacturers file the most rigorous application for marketing, a pre-market approval (PMA) application, to demonstrate safety and effectiveness for most uses and establishing new special controls that manufacturers must follow for other uses. 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. “We remain committed to ensuring patients have access to reasonably safe and effective medical devices using the most current and scientifically robust information available.”
The U.S. Food and Drug Administration today published the final order, Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses, that requires the filing of a premarket approval (PMA) application for most uses of Electroconvulsive therapy (ECT) devices and reclassifies ECT devices for the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder from Class III (higher risk) to Class II (moderate risk) with special controls. ECT devices are one of two device types remaining to be classified through the 515 Program Initiative. This was implemented to facilitate the FDA’s final classification actions for Class III devices that were in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments, but were never required to submit PMA applications. The FDA is aware of two manufacturers of ECT devices in the U.S.
The final order requires ECT manufacturers to file a premarket approval (PMA) application for all uses that are not being reclassified to class II, such as schizoaffective disorder and bipolar manic states, because the FDA is unable to identify sufficient information to establish special controls to provide a reasonable assurance of safety and effectiveness of ECT devices for such indications.
The reclassified uses for ECT devices into Class II are limited to the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients age 13 years and older who are treatment-resistant or who require a rapid response treatment due to the severity of their psychiatric or medical condition. The safe use of ECT for treatment of these conditions has been well studied and is better understood than other uses. Therefore, sufficient information exists to establish special controls that mitigate known risks and provide a reasonable assurance of safety and effectiveness for these two uses of ECT devices. Manufacturers of ECT devices for the indications above will now need to submit information to the agency to demonstrate their devices are in compliance with these special controls.
The final order goes into effect Dec. 26, 2018. The order contains an implementation section to inform manufacturers about specific timelines and processes, depending on the indications for use they are seeking.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.