Zdrowie i gospodarka · 22/01/2016

FDA Proposes Changes to Cranial Electrotherapy Stimulator Devices

The FDA is proposing to reclassify cranial electrotherapy stimulator devices intended to treat insomnia and/or anxiety from Class III to Class II, requiring premarket notification and premarket approval for devices treating depression, based on new information and clarifying the device's classification as a prescription device for psychiatric conditions.