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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Electro-shock controversy: Psychiatrists and skeptic patient advocacy groups remain split on the safety and efficacy of electroconvulsive shock therapy devices. After requiring manufacturers of certain "pre-amendment" Class III devices, including ECT devices, to submit safety and effectiveness information, FDA opened a docket to allow the public to weigh in as the agency decides whether to require PMAs for the devices or downclassify them (1"The Gray Sheet" Sept. 14, 2009). The psychiatric community maintains that ECT is a safe and effective treatment option for psychiatric disorders such as severe depression. "When patients are appropriately screened and ECT is appropriately delivered, there is no question about its efficacy in a significant percentage of very ill patients," Cleveland Clinic's Donald Malone, M.D., comments. "Requiring a PMA of the current ECT device companies would place a tremendous burden on relatively small companies." Others, such as the Center for Disability Rights, oppose down-regulation. Because of the "severe danger" of electro-shock, the procedure is banned in Texas for children under age 16, noted one psychologist who urged FDA to require PMAs for ECT devices. Though not a booming market, ECT is still used in some facilities; manufacturers include Mecta Corporation (SpECTrum) and Somatics (Thymatron)
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