ECT Makers Seeking Class II for Pre-Amendment Devices

With the FDA selecting electroconvulsive therapy (ECT) machines as the first of 25 types of Class III pre-amendment devices to undergo review of their classification, manufacturers are concerned about their survival if the product is not designated Class II. The agency is reviewing the ECT machines, which are used to treat extreme depression, first as a result of “significant public interest” in the devices, it says in a notice published recently in the Federal Register.
Devices & Diagnostics Letter