Guest guest Posted December 31, 2009 Report Share Posted December 31, 2009 Dear Friends, We are being heavily out-commented by psychiatrists and their front groups to the FDA regarding Electric Shock machines and must act fast. Please let me know after you have commented. Unlike other medical devices, the ECT machine (electro-convulsive therapy) has never been FDA tested for safety. It is considered a Class III medical device based upon potential danger. The FDA is now being forced to test the machine. The testing is for pre-market approval which has never been done. To counter this, the American Psychiatric Association if working to get the FDA to classify the ECT machine as a Class II device – a category of less dangerousness wherein the FDA would never have to test the shock machines. Please email or write the Food and Drug Administration now until January 8, 2010 (now would be best) and _tell them in your own words:_ /I oppose the reclassification of the ECT device to Class II in the absence of adequate scientific evidence of its safety, and request that the FDA call for PreMarket Approval Applications for the device./ Comments can be mailed or emailed but must include the docket number, which is FDA 2009-N-0392. The address for written comments is: Food and Drug Administration Dockets Management Branch (HFA-305) 5630 Fishers Lane, Room 1061 Rockville, MD 208252 Re: Docket #FDA 2009-N-0392 Email at: http://bit.ly/FDAECT [for category of person you can choose 'Individual Consumer' – pick the closest that you think will apply. For organization you can put in 'self'] Below is my message as an example: “Docket #FDA 2009-N-0392 I have a friend who lost skills such as the ability to play guitar and was also disoriented for years due to ECT. The shock machines have never been FDA tested for safety and the concept of avoiding this by making it a Class 2 device is a complete scam. " It's dangerous and untested. Keep it Class 3, test the device and let the public know. " Thanks, Hall CCHR New England Director (held from above) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 31, 2009 Report Share Posted December 31, 2009 Dear Friends, We are being heavily out-commented by psychiatrists and their front groups to the FDA regarding Electric Shock machines and must act fast. Please let me know after you have commented. Unlike other medical devices, the ECT machine (electro-convulsive therapy) has never been FDA tested for safety. It is considered a Class III medical device based upon potential danger. The FDA is now being forced to test the machine. The testing is for pre-market approval which has never been done. To counter this, the American Psychiatric Association if working to get the FDA to classify the ECT machine as a Class II device – a category of less dangerousness wherein the FDA would never have to test the shock machines. Please email or write the Food and Drug Administration now until January 8, 2010 (now would be best) and _tell them in your own words:_ /I oppose the reclassification of the ECT device to Class II in the absence of adequate scientific evidence of its safety, and request that the FDA call for PreMarket Approval Applications for the device./ Comments can be mailed or emailed but must include the docket number, which is FDA 2009-N-0392. The address for written comments is: Food and Drug Administration Dockets Management Branch (HFA-305) 5630 Fishers Lane, Room 1061 Rockville, MD 208252 Re: Docket #FDA 2009-N-0392 Email at: http://bit.ly/FDAECT [for category of person you can choose 'Individual Consumer' – pick the closest that you think will apply. For organization you can put in 'self'] Below is my message as an example: “Docket #FDA 2009-N-0392 I have a friend who lost skills such as the ability to play guitar and was also disoriented for years due to ECT. The shock machines have never been FDA tested for safety and the concept of avoiding this by making it a Class 2 device is a complete scam. " It's dangerous and untested. Keep it Class 3, test the device and let the public know. " Thanks, Hall CCHR New England Director (held from above) Quote Link to comment Share on other sites More sharing options...
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