FDA Draft Guidance for Industry, Clinicians and FDA Staff

Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses

Document issued on: December 29, 2015

This draft guidance document provides draft recommendations for 510(k) submissions and compliance with special controls being proposed to support reclassification of Electroconvulsive Therapy (ECT) Devices into class II (special controls) for severe major depressive episode (MDE) associated with Major Depressive Disorder (MDD) or Bipolar Disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.

An ECT device is an electrical device used for treating severe psychiatric disturbances by applying a brief intense electrical current to the patient’s head to induce a major motor seizure. This guidance is issued for comment purposes only.

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Download “Electroconvulsive Therapy Devices” UCM478942.pdf – Downloaded 338 times – 715 KB

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Signs, Symptoms, and Treatment of Depression

Last Updated: 2015-12-29

FDA Guidance for Electroconvulsive Therapy Device 510Ks
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