FDA Resources
FDA Dockets
- 1990 Docket Exerpts
- 2009-2010 Docket –
- 2016 Docket – 2015-32592
- 2016 Reclassification Draft Guidance – FDA-2014-D-1318
FDA Resources
- How to Report your injuries to the FDA
- The FDA’s Regulation of ECT (Shock Treatment): A Beginner (or Refresher) Course
- Doctors of Deception, What they Don’t Want You to Know About Shock Treatment
FDA Blog Posts
The Hidden Harms of Electroshock Therapy: A Womans Plea to the FDA - Docket #82P-0316
Theresa had 32 ECT sessions in 1989 and experienced severe memory loss, cognitive problems, and a decline in her quality…
Excerpts from 1990 FDA ECT Dockets
Exerpts from ECT recipeints submissions the 1990 FDA dockets.
Electroconvulsive therapy and FDA adverse reporting - our findings and future goals
This spring, Life After ECT launched a comprehensive FDA reporting guide for injured electroconvulsive therapy (ECT) recipients. This post is…
ECT Device Reclassification Draft Guidance - Moira Dolan MD to the FDA, 2016
Moira Dolan MD to the FDA regarding ECT draft guidance for the 2016 electroshock device risk reclassifacation.
The Controversial History of ECT -- An Interview with Linda Andre
ECT survivor activist and author Linda Andre talks about her book, Doctors of Deception, What They Don’t Want You to…
ECT Device Safety: Attorney Barry Kade to the FDA, 2009
Attorney Barry Kade to the FDA, ECT device reclassification, 2009.
ECT Device Safety - New York Association of Psychiatric Rehabilitation Services (NYAPRS) to the FDA, 2010
ECT Device Safety - New York Association of Psychiatric Rehabilitation Services (NYAPRS) to the FDA, 2010
ECT Device Safety : Center for the Human Rights of Users and Survivors of Psychiatry to the FDA
Center for the Human Rights of Users and Survivors of Psychiatry to the FDA, 2009
ECT Safety Reclassification: Psych Rights to FDA
Psych Rights to FDA on the 2016 ECT device safety reclassification.
ECT Safety Reclassification: The Committee for Truth in Psychiatry to the FDA
Linda Andre on behalf of the Committee for Truth in Psychiatry to the FDA, 2016 ECT device reclassification.
ECT Safety Reclassification: Psychiatrist Daniel P. Fisher to FDA, 2011
Psychiatrist Daniel P. Fisher to the FDA on the ECT device reclassifications, 2011.
ECT Safety Reclassifcation - Mental Hygiene Legal Service to FDA, 2009
We are attorneys with a public agency concerned with mental health issues in New York State, and in that context…
ECT Safety: Depression and Bipolar Support Alliance (DBSA) to FDA
Depression and Bipolar Support Alliance (DBSA) on ECT device safety reclassification.
Leonard Roy Frank to the FDA, ECT Safety Reclassification
Forced insulin coma and electroshock survivor Leonard Roy Frank shares his perspectives with the FDA on ECT device safety reclassification.
ECT Device Safety - Nebraska Advocacy Services to FDA
Nebraska Advocacy Services, Inc., The Center for Disability Rights, Law, and Advocacy, supports the continued categorization of electroconvulsive therapy (ECT)…
ECT Safety Reclassification - Mental Health Empowerment Project, Inc.
The use of electroshock is a consistent concern of MHEP, particularly when it is forced, court-ordered, or delivered without informed…
ECT Safety Reclassification - National Council on Independent Living (NCIL) to FDA, 2009
Individuals with mental illness are at a very high risk of becoming victims of violence and abuse; and victims of…
ECT Device Reclassification: MindFreedom International to FDA, 2009
On behalf of MindFreedom International, this letter is to absolutely oppose the FDA's proposed reclassification of the device used for…
ECT Device Reclassification: The Law Project for Psychiatric Rights to the FDA, 2009
The Law Project for Psychiatric Rights (PsychRights®) is writing to oppose the reclassification of electroconvulsive therapy devices (Electroshock Machines) as…
ECT Device Reclassification - The Mental Health Consumer/Survivor Network of Minnesota to FDA, 2009
while other medical devices have had to undergo the rigorous safety investigation known as PreMarket Approval (PMA), the FDA has…