It’s easier than ever to comment on the web about electroshock before the deadline Friday, 8 January 2010. The US Food & Drug Administration never got around to investigating the device used for electroconvulsive therapy (ECT or electroshock) for safety and efficacy. But rather than do their job, and regulate the shock device, the FDA is instead proposing to give the device a rubber stamp of approval.
ACTION: ZAP BACK to Stop FDA Rubber Stamping Electroshock Device!
NEW EASY WAY ON THE WEB TO COMMENT TO FDA!
Your deadline is Friday, January 8, 2010.
And numbers count!
At the time of this update, comments in favor of the electroshock industry are outnumbering comments critical of electroshock!
To go directly to the ‘comment form’ on the FDA web site, and submit your online comment, go here:
At the least say, “I oppose the FDA’s proposed reclassification of the ECT device to Class II. The FDA should investigate the ECT device for safety. The FDA should call for Pre-Market Approval Applications for the device.”
More information via FDA web site
Here is an alternative way to use the FDA web site, so that you have the option of looking at other comments, the FDA notice itself, or making a comment:
1) Go to the FDA web site here:
2) In “Select Document Type” use the pull-down menu for:
3) In “Enter Keyword or ID” insert this docket number:
4) Then click “Search”
5) You should now see a blue link at the bottom left entitled:
“Medical Devices: Neurological Devices; Electroconvulsive Therapy Device; Establishing a Public Docket”
You may now do any of the following three things:
- READ THE FDA NOTICE: Click the blue-linked title to read the FDA Notice itself. When you are done, at TOP of that Notice you may click the button ‘submit comment’.
- SUBMIT COMMENT: Skip reading the notice, and under “Action” on right hand side, click the blue-linked “Submit a Comment”
- READ OTHER COMMENTS: Browse the other published online public submissions already submitted by clicking “Open Document Folder.” If you submit online comments, your note should eventually appear here as part of the permanent public record.
** POSTAL MAIL COMMENTS TO FDA:
No access to web?
Be sure to give that docket number – 2009-N-0392 – and postal mail your comments postmarked by 8 January 2010 to:
Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852 USA
WHAT TO SAY TO THE FDA?
- Be sure to say point blank you are AGAINST reclassification, and why.
- Most helpful is if you can provide even a few specific substantive points, with citations and reasoning, about why reclassification is all wrong. You may want to read more about electroshock.
- FDA is supposed to make decisions according to law and science. Therefore, use scientific evidence and reasonable logic in your comment.
- Always give the FDA docket number 2009-N-0392.
- You may attach or copy whole articles or citations to back up your points.
- Submit articles or references in English. If an article or citation is not in English, you need to provide the original material and a translation into English by a ‘qualified translator.’
- Be civil and professional. Inappropriate comments may be used against the effort to prevent reclassification. Threats may be referred to law enforcement officials.
- Your input must be postmarked or delivered in person by 8 January 2010, no exceptions.
What if you do not have time for detailed comments?
If you are not able to research and make specific points, then even a very brief comment against reclassification is helpful to show widespread public concern!
If you are not in a position to write anything up, PsychRights and CTIP recommend the following brief message which you can send either online or by mail.
Copy and paste this coupon into a text document, fill out, and submit via web or postal mail.
To: Food and Drug Administration
Dockets Management Branch (HFA-305),
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Electroconvulsive Therapy Device (882.5940), Docket #FDA-2009-N0392
The undersigned opposes the reclassification of the ECT device to ClassII by the FDA in the absence of adequate scientific evidence of itssafety, and asks the agency to call for PreMarket ApprovalApplicationsfor the device.
Signature [if postal mail]: ________________
FOR THOSE WHO WERE PERSONALLY HARMED BY ELECTROSHOCK: Consider submitting a report via MEDWATCH
If you have directly experienced harm from ECT it is also important to provide your account to MEDWATCH at the following address:
Or use this link:
Click on “BEGIN” on the right hand side of the page. In MEDWATCH you will need to pick your own ‘patient identifier’ such as your initials so that the submission can be referenced anonymously in the future. At any point you may click ‘help’.
Below see links to related content on the campaign to speak out to the FDA.