FDA Panel Wants Electroconvulsive Therapy to Retain High-Risk Class III Status

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The US Food and Drug Administration’s (FDA’s) Neurological Devices Panel has told the FDA that it wants electroconvulsive therapy (ECT) machines to retain their class III classification as high-risk devices.

The FDA had been seeking advice and recommendations from the panel as to whether regulations on ECT machines should be relaxed, but it did not ask the panel to formally vote on the matter.

Retaining their current class III classification means that the devices may be subject to a more stringent premarket approval process and that the 2 current manufacturers in the United States — MECTA and Somatics — might have to seek a premarket approval (PMA) and conduct the appropriate clinical trials to provide new evidence showing that the devices are indeed safe and effective for the treatment of severe, drug-resistant depression and other severe psychiatric illness…..

Fran Lowry
Medscape Medical News
http://www.medscape.com/viewarticle/736697

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