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FDA Reclassifies Some ECT Devices

Posted 21 December 2018 | By Zachary Brennan 

FDA Reclassifies Some ECT Devices

Electroconvulsive therapy (ECT) devices used for the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder have been reclassified from Class III (higher risk) to Class II (moderate risk) with special controls.

“The safe use of ECT for treatment of these conditions has been well studied and is better understood than other uses,” FDA said in making the decision. “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.”

Although filing a premarket approval (PMA) application is still necessary for most uses of ECT devices, manufacturers for the two reclassified indications will now need to submit information to FDA to demonstrate their devices comply with these special controls. The agency said it was aware of two ECT device manufacturers in the US.

“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 agency said.

Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses
 

Categories: Regulatory News

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