The US FDA announced that on January 27 and 28, 2011, a US Food & Drug Administration committee will “discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.”
| What |
|
|---|---|
| When | Jan 27, 2011 08:00 AM to Jan 28, 2011 06:00 PM |
| Where | Gaithersburg, MD |
| Contact Name | James Engles, FDA |
| Contact Phone | 301-443-0572 code 3014512513 |
| Attendees | All are welcome. |
| Add event to calendar | vCal iCal |
MindFreedom Zapback Initiative News – 9 December 2010
US Federal Committee To Have Meeting About Electroshock Devices
Location of FDA meeting:
Hilton Washington DC North/Gaithersburg, Ballroom, 620 Perry Pkwy., Gaithersburg, MD.
More info from FDA web site:
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm234979.htm
Background:
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The FDA has appointed an advisory committee to assist it to determine if electroconvulsive therapy (also known as electroshock) devices will be moved from Class III to Class II, or as many have proposed, to require the manufacturers to submit a “Pre-Market Application” which they should have been required to do 35 years ago.
If the Committee agrees to downgrade the risk of ECT to Class II, it will be more readily available, and the manufacturers may never have be required to prove either that it is safe, nor that it is effective.
ECT survivors may briefly speak to the committee in this public meeting to provide their story or perspective on the harms caused to them by ECT.
Communication of long term harms is especially important, as the manufacturuers and ECT advocates are minimizing ECT long term ill effects – such as long term memory loss, as well as long term effect of reducing ability to learn and remember new information.
The FDA states that persons wishing to speak at this important meeting may contact James Engles at James.Engles@fda.hhs.gov. While a deadline of 14 January is listed to ask to speak, the sooner the better.
There will certainly be psychistrists and manufacturers representatives and others claiming ECT is a life saving treatment. The Committee needs to hear from people who know the true risks of electroshock.
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