FDA proposes reclassifying ECT - Comments due by Mar. 28
Five years after it last broached the matter, the Food and Drug Administration (FDA) is again proposing to reclassify electroconvulsive therapy (ECT) from a Class III (high risk) medical device to Class II (low risk). APA supports this change.
Opposition from anti-psychiatry groups was blamed for the FDA's maintaining the Class III status in 2011. Opponents to reclassification argued then that ECT causes memory problems, cognitive impairment, and other adverse effects. Supporters noted that current ECT practices, using anesthesia and muscle relaxants, significantly reduce those effects.
APA urges psychiatrists to contribute their comments to the FDA in favor of the reclassification. A template form letter has been prepared that provides talking points. The FDA’s draft guidance on the proposed reclassification and a link to post comments can be accessed here. The FDA must receive comments by March 28.