Theresa had 32 ECT sessions in 1989 and experienced severe memory loss, cognitive problems, and a decline in her quality of life. Her letter to the FDA (Docket #82P-0316) urges the FDA to keep the ECT device at class III.
FDA Resources FDA Dockets 1990 Docket Exerpts2009-2010 Docket -Document ID FDA-2009-N-0392-00012016 Docket - Federal Register Number 2015-325922016 Reclassification Draft Guidance - Docket ID FDA-2014-D-1318FDA Resources How to Report your injuries to…
Exerpts from ECT recipeints submissions the 1990 FDA dockets.
This spring, Life After ECT launched a comprehensive FDA reporting guide for injured electroconvulsive therapy (ECT) recipients. This post is a progress update and an overview of our future reporting goals.
Moira Dolan MD to the FDA regarding ECT draft guidance for the 2016 electroshock device risk reclassifacation.
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
Center for the Human Rights of Users and Survivors of Psychiatry to the FDA, 2009