Editing Electroconvulsive therapy (section)

==== Regulation ====
In the US, ECT devices came into existence prior to medical devices being regulated by the [[Food and Drug Administration]]. In 1976, the [[Medical Device Regulation Act]] required the FDA to retrospectively review already existing devices, classify them, and determine whether clinical trials were needed to prove efficacy and safety. The FDA initially classified the devices used to administer ECT as [[Medical devices#Class III: General controls, Special Controls and premarket approval|Class III medical devices]]. In 2014, the [[American Psychiatric Association]] petitioned the FDA to reclassify ECT devices from Class III (high-risk) to Class II (medium-risk). A similar reclassification proposal in 2010 did not pass.<ref>{{cite web| vauthors = Levin S, Binder R |title=Time Is Now to Support the ECT Reclassification Effort|url=https://www.psychiatry.org/news-room/apa-blogs/apa-blog/2016/01/time-is-now-to-support-the-ect-reclassification-effort|website=American Psychiatric Association|access-date=23 April 2017}}</ref> In 2018, the FDA re-classified ECT devices as Class II devices when used to treat catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder.<ref name=":1"/>