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Electroconvulsive Therapy Devices: FDA Proposes 510(k), Special Controls

This article was originally published in The Gray Sheet

Executive Summary

FDA is proposing to reclassify electroconvulsive therapy devices aimed at treating major depressive disorder to class II with special controls, but require PMAs for other indications. The proposal does not align with a 2011 FDA panel recommendation to keep ECTs for depression in the class III category and require PMAs.

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