FDA Panel Endorses PMAs For Electroshock Therapy Devices
This article was originally published in The Gray Sheet
Executive Summary
A recent vote by an FDA advisory panel favoring more stringent regulation of electroconvulsive therapy devices is not likely to jeopardize future availability of the products on the market, according the panel's chairman.
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FDA Lowers Age For Electroshock Devices From 18 To 13 In Final Order; Gives Makers Of Down-Classified ECTs 6 Months To Submit 510(k) Amendments
A Dec. 26 final administrative order from FDA says people as young as 13 who suffer from major depressive disorders can now be treated with electroconvulsive therapy (ECT) devices that have been newly down-classified by the US agency, from high-risk class III to moderate-risk class II with special controls. Manufacturers of ECT devices covered by the final order have 180 days to submit an amendment to their product's 510(k) that shows how their device meets the special controls. Meanwhile, makers of class III ECT devices that were not redesignated as class II must file a pre-market approval application with FDA within 90 days.
Electroconvulsive Therapy Devices: FDA Proposes 510(k), Special Controls
FDA is proposing to reclassify electroconvulsive therapy devices aimed at treating major depressive disorder to class II with special controls, but require PMAs for other indications. The proposal does not align with a 2011 FDA panel recommendation to keep ECTs for depression in the class III category and require PMAs.
Class Act: Status Of CDRH’s 515 Initiative
Chart updating FDA’s progress and decisions in classifying the final set of preamendment devices.