martes, 29 de diciembre de 2015

CDRH Industry: Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses - Draft Guidance for Industry, Clinicians and FDA Staff

The draft guidance, "Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses" has recently been posted.  This 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 This guidance is issued for comment purposes only.

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