(March 14, 2016) FDA to declassify electroshock therapy to same risk category as condoms and contact lenses
The Food and Drug Administration is set to allow for the dramatic expansion of electroshock therapy for patients who have been diagnosed with clinical depression, through reclassification of the devices used to deliver shock treatment, despite the fact that experts and former patients have attested to the damage such treatment causes.
As noted by mental health watchdog organization Citizens Commission on Human Rights International (CCHRI), the FDA began the reclassification process for Electroconvulsive Therapy Devices (ECT) in early January.
The change would lower the devices from their current highest-risk Category III classification, "to allow electric shock machines to be utilized in the treatment of specific alleged mental illnesses with less regulatory controls," the organization noted in an alert.
The change, detailed here at Regulations.gov, is being sought, "despite the federal agency's admission that the ECT device has not been proven safe and effective," CCHRI noted further, adding that to date, some 5 million Americans have been given ECT treatments without their manufacturers having been required to submit valid scientific evidence (like clinical trials), that they were safe and effective.