Abstract: Electroconvulsive therapy (ECT) and the machines that deliver it have never been tested for safety and efficacy in order to receive approval from the FDA. The American Psychiatric Association and ECT advocates protested when the FDA took steps to classify the machines as posing “an unreasonable risk of illness or injury”, which would have required their testing before approval. Without requiring this testing, the FDA is now preparing to classify the treatment and the machines as safe. This article reviews evidence demonstrating that ECT is very harmful to the brain and mind, and concludes that the FDA should demand the usual testing, starting with animals, that is required before psychiatric treatments and machines are approved for marketing and use.