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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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