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AAGP Files Comments on ECT Reclassification

On December 16, 2009, AAGP filed comments with the Food and Drug Administration (FDA) urging the reclassification of electroconvulsive therapy (ECT) devices as a Class II device, based on the strong evidence of ECT's safety and efficacy.

The reclassification issue has arisen because, without it, the FDA may require ECT device manufacturers to submit pre-market approval applications. The small companies that make the devices might have difficulty finding the resources to prepare these applications or to conduct new large-scale clinical trials that could also be required. AAGP is concerned such action by the FDA would negatively impact the availability of ECT in the United States.

ECT devices were classified in 1976 as Class III devices, the class that indicates the highest risk for safety and efficacy. Because they were already on the market when the pre-market approval process was instituted, they were not required to go through the process. The Class III definition requires a higher standard because of insufficient information on safety and efficacy.

FDA has now undertaken to either reclassify the devices that had previously been accepted into the system in 1976 or to require full pre-market applications. FDA has requested submission of information on safety and efficacy of these devices as it considers its decision. In its comments, AAGP agreed with the American Psychiatric Association and other professional organizations that the effectiveness and safety of ECT are well documented.

AAGP also noted that most of the recent increase in the use of ECT has been in the elderly, probably because older patients may be more likely to present with particularly severe forms of depression or to have depression associated with certain brain changes or medical conditions that may lower the likelihood of successful treatment with medications but not with ECT. Although response to ECT for appropriate indications is very high in all age groups, recent research has suggested that older age is actually a positive predictor of response to ECT.

For AAGP's comments to the FDA, visit www.AAGPonline.org/advocacy/letter.asp?id=21.

 

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