Guest guest Posted January 8, 2010 Report Share Posted January 8, 2010 Note: "electroconvulsive therapy" = "electroshocks"==========ALLIANCE FOR HUMAN RESEARCH PROTECTION A Catalyst for Public Debate: Promoting Openness, Full Disclosure, andAccountability http://www.ahrp.org FYI and ActionIf you are concerned about the possibility that the FDA may exemptmanufacturers of electroconvulsive therapy (ECT) devices from the regulatoryrequirement to prove their devices safe and effective through the PreMarketApproval (PMA) process, tomorrow, Jan. 8th is your last chance to send inyour comments:The identification of the proposed rule change is: FDA-2009-N-0392You can post comments at:http://www.regulations.gov/search/Regs/home.html#homeor call: 1-877-378-5457 (very helpful staff)or email: regulations.gov_helpdeskThis is a very contentious proposition advocated by--needless tosay--manufacturers of ECT devices and a powerful cadre of psychiatrists whoare financially invested in the business of ECT.The issue is about safety and honest disclosure about the documented andpotential risk of harm--primarily memory loss following electroshock.There is a large backlog in the posting of comments received by the FDAabout this issue--See AHRP public comments submitted to the FDAhttp://www.ahrp.org/cms/images/stories/articles/fda%20ect%20classification.pdfContact: Vera Hassner Sharavveracare212-595-8974=====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. Quote Link to comment Share on other sites More sharing options...
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