Update on FDA Panel on ECT Devices

FDA advisory panel recommends more testing of ECT devices.

The New York Times(1/29, B7, Wilson) reports that after a two-day meeting, the Food and Drug Administration’s Neurological Devices Advisory Committee “was sharply divided on Friday about whether to recommend that regulators designate electroshock devices as high risk.”  

The Washington Post (1/29, Brown) reported, “The majority of the 18-member committee said not enough is known about ECT…to allow the devices to be used without more research into its usefulness and hazards.” Should the FDA follow “the panel’s advice, which it usually does, the two companies whose machines are used in the United States will have to provide evidence of the therapy’s safety and effectiveness either from existing research or new studies.” But, “if the FDA isn’t convinced, the devices could be removed from use,” the Post explained.