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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Electro-shock comments: FDA will accept public comments through Jan. 8 on electro-shock therapy devices in response to a "significant number of inquiries from members of the public and the health care community," the agency says. Electroconvulsive therapy systems are among the 27 device types available prior to the 1976 Medical Device Amendments, for which new versions can reach the market via 510(k) clearance, though they have not been formally risk-classified by FDA. The agency ordered makers of ECT devices and 24 other product types to submit safety and effectiveness information by Aug. 7 to inform FDA's decision on whether to down-classify the products to Class I or II, or require PMA applications (1"The Gray Sheet" Aug. 17, 2009). The new docket allows individuals other than manufacturers to submit information on the safety and efficacy of ECT devices. FDA did not specify the source of the inquiries leading to the comment opening, but there has been substantial debate among the psychiatric establishment, which generally supports 510(k) access for ECT devices, and skeptic groups, such as the Committee on Truth in Psychiatry, an organization of former shock therapy patients who push for more substantial regulation

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Regulatory News In Brief

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)

Regulatory News In Brief

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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