FDA Reclassifies Electroconvulsive Therapy Devices as Moderate Risk in Certain Cases

January 7, 2019 | Strategic Insights for Ambulatory Care


​The U.S. Food and Drug Administration (FDA) on December 26, 2018, published a final order reclassifying electroconvulsive therapy (ECT) devices for certain uses from Class III (higher risk) to Class II (moderate risk).

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