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.