|2003P-0555 - Maintain the Electroconvulsive Therapy Device in Class III for All Indications|
|FDA Comment Number :||EC14|
|Submitter :||Ms. Kimberly Moody||Date & Time:||03/22/2004 02:03:57|
|Organization :||Disability Rights Center|
| Food and Drug Administration, Dockets Management
Re: Docket #2003P -0555
5630 Fishers Lane, Room 1061
Rockville, MD 20852
As we did nearly 20 years ago, Maine's Protection and Advocacy organization for people with disabilities, the Disability Rights Center, strongly urges the FDA to conduct a safety investigation of electroconvulsive therapy (ECT). Until that safety investigation proves that ECT is safe, it is imperative that the FDA not reclassify the ECT device from Class III to Class II.
On behalf of the Disability Rights Center and the clients we serve, I cannot urge you strongly enough to abandon this reclassification. As we said in 1987, we have seen no evidence of the safety of ECT and in fact, have all too often worked with clients who experience severe and persistent negative side effects from the procedure.
Again, prior to reclassifying the ECT device based on your own review, we request that you conduct a safety investigation, as per your own standard past practices.
Thank you for your attention to this very important matter.
Disability Rights Center