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Zdrowie i gospodarka · 26/12/2018

FDA Reclassifies Electroconvulsive Therapy Devices for Certain Uses, Requires Premarket Approval

The FDA is reclassifying electroconvulsive therapy devices for use in treating severe cases of depression and bipolar disorder in patients 13 and older, requiring premarket approval for other uses, as part of a new regulation aimed at improving safety and efficacy

Source: Federal Register — Food and Drug AdministrationOpen original release →