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Reclassification of ECT Devices

Approved by the Joint Reference Committee, February 2019

  • 2019

Resource Document on the FDA Final Order to Reclassify ECT Devices

Approved by the Joint Reference Committee, February 2019

On December 26, 2018, the Food and Drug Administration (FDA) issued a final order regarding the reclassification of devices for administration of electroconvulsive therapy (ECT).i On the basis of device risk and the steps needed to give reasonable assurance of safety and effectiveness, the FDA categorizes medical devices into one of three classes (Class I, II, or III), with Class I devices generally posing the lowest risk to the patient.ii As part of a broader statutory requirement to re-categorize class III devices that were marketed prior to May 28, 1976,iii the FDA evaluated evidence related to the effectiveness and safety of ECT, convened a meeting of its Neurological Devices Advisory Panel to evaluate the effectiveness and safety of ECT devices, published a draft order on the reclassification of ECT devices and reviewed over 3,400 public comments related to the draft order. The American Psychiatric Association (APA) participated in this process by providing testimony at the Neurological Devices panel hearing and by submitting detailed comments on the draft order.

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