ECT Makers Could Exit US Market if FDA Requests New Data

Electroconvulsive therapy (ECT) device manufacturers may pull their devices off the U.S. market if the FDA decides to back an advisory panel suggestion to formally classify ECT machines as Class III. “If the FDA does not put ECT devices in Class II, the U.S. will become the first major country in modern times to prevent ECT devices from being available for treatment,” Conrad Swartz, co-owner of Somatics, a domestic manufacturer of ECT, said. “ECT certainly will continue to exist in other countries.” While no formal vote was taken, the majority of the 18-member panel felt that there weren’t enough data currently available to justify making ECT Class II.
Devices & Diagnostics Letter