January 5

FDA May Relassify ECT devices

If you are concerned about the possibility that the FDA may exempt manufacturers of electroconvulsive therapy (ECT) devices from the regulatory requirement to prove their devices safe and effective through the PreMarket Approval (PMA) process, tomorrow, Jan. 8th is your last chance to send in your comments:

The identification of the proposed rule change is: FDA-2009-N-0392 You can post comments at:

or call: 1-877-378-5457 (very helpful staff)

or email: regulations.gov_helpdesk@bah.com

This is a very contentious proposition advocated by–needless to say–manufacturers of ECT devices and a powerful cadre of psychiatrists who are financially invested in the business of ECT.

The issue is about safety and honest disclosure about the documented and potential risk of harm–primarily memory loss following electroshock.

There is a large backlog in the posting of comments received by the FDA about this issue–

See AHRP public comments submitted to the FDA: Click here for full article

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