2003P-0555 - Maintain the Electroconvulsive Therapy Device in Class III for All Indications
FDA Comment Number : EC17
Submitter : Mr. John Lowary Date & Time: 04/13/2004 12:04:38
Organization : PAIMI Board Member
Individual Consumer
Category :
Issue Areas/Comments
GENERAL
GENERAL
Please keep current Class III as they are. Do not lower the standards from Class III to Class II. People need the protections already in place. They do not need a relaxation of these stndards.