Electroconvulsive Therapy Devices: FDA Proposes 510(k), Special Controls
This article was originally published in The Gray Sheet
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.
You may also be interested in...
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.
Companies are suspicious of FDA motivations in the drawn-out reclassification process for cranial electrotherapy stimulators. But the case also underscores how the agency's efforts to place devices in the appropriate risk category turns not only on the perceived safety of a device, but evidence supporting its benefits and the types of evidence the agency is comfortable accepting.
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.