Devices

Petition Seeks ECT Device Ban

A citizen petition filed on behalf of five individuals who were damaged by electroshock therapy (also known as electroconvulsive therapy or ECT) asks FDA to either ban use of the devices or keep them in Class 3 and set a date for premarket approval for all such devices. The petition notes that an agency 12/2015 proposed order would down-classify devices used to deliver electroshock therapy to Class 2.

A media statement (includes link to petition) issued by FDA gadfly attorney Jonathan Emord, who filed the petition, says that while many people believe that ECT went the way of lobotomies, in fact it is conservatively estimated that over 100,000 individuals receive ECT treatments each year in the U.S. Emord says that actual numbers are not available because the treatments are not tracked.

ECT devices have never gone through standard clinical trials to establish safety and efficacy, Emord says. He says that FDA has said that the treatment can cause cognitive impairment, memory impairment, prolonged seizures, dental trauma, manic symptoms, pulmonary complications, worsening of psychiatric symptoms, and death. The agency has requested studies a number of times, Emord says, and the manufacturers have ignored the requests each time.

“FDA has neglected to follow through,” he says, “failing to take action to protect the public. Instead, FDA issued the proposed order to reclassify the device to a safer category, in the absence of clinical trial data establishing safety.” Emord says the petition cites numerous FDA violations of the Administrative Procedures Act in issuing the proposed rule to down-classify the devices. “The petition makes a strong case that, in issuing the proposed order, FDA’s actions constitute an ‘abuse of discretion and arbitrary and capricious agency action,’” he concludes.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome