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FDA considers classification of ECT

posted Wednesday, 23 December 2009

Psychiatry Weekly 2009 Dec 21;4(30)

Lisanby SH.

Professor of Clincal Psychiatry; Director of the Brain Stimulation Division, Columbia University/New York State Psychiatric Institute

Introduction

With the increasing number of new brain stimulation techniques now available and on the horizon, does electroconvulsive therapy (ECT) still have a role? As a clinician and researcher, my reply is a definitive "yes." Some recent and unexpected developments at the FDA concerning the classification of medical devices may, however, affect the availability of ECT to severely depressed patients.

History of ECT Classification

Codified in 1938, the FDA is nearly as old as ECT. The FDA was codified with the Federal Food, Drug, and Cosmetic Act during the same year that Cerletti and Bini introduced ECT in Italy (though Meduna introduced chemoconvulsive therapy two years prior). When the Medical Device Amendments were introduced in 1976, ECT devices were already on the market in the US. They are thus considered "pre-amendment" devices, meaning they did not go through the premarket approval application (PMA) route that devices introduced after 1976 are required to go through today.

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© 2009 Psychiatry Weekly, LLC

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