The Food and Drug Administration's (FDA's) pending decision on the reclassification of electroconvulsive therapy (ECT) devices may significantly affect patient access to the effective and potentially life-saving treatment for severe depression. <br><br>
According to the 1976 amendments to the federal Food, Drug, and Cosmetic Act, medical devices must be proven safe and effective in clinical trials, and the data must be submitted, reviewed, and approved by the FDA before the devices can be marketed. Devices that were on the market before 1976, including ECT devices, were given a Class III designation and allowed to continue to be sold without going through the premarketing approval process. <br><br>
In April 2009, the FDA issued an order to require manufacturers of devices that had not been formally reviewed, including ECT devices, to submit clinical data to support the products' efficacy and safety. In a notice published in the Federal Register on September 10, 2009, the FDA opened a docket to obtain public comments on how ECT devices should be reclassified.