2003P-0555 - Maintain the Electroconvulsive Therapy Device in Class III for All Indications
FDA Comment Number : EC16
Submitter : Dr. Sylvia Caras Date & Time: 04/08/2004 03:04:42
Organization : People Who
Individual Consumer
Category :
Issue Areas/Comments
GENERAL
GENERAL
Maintain ECT in Class III. There is sufficient evidence of brain damage and memory loss to keep these devices under strict scrutiny and ensure mandatory safety investigations.