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Tens of Thousands Injuries and Death Reports Linked to Medical Devices Cleared by the FDA with Limited Testing

According to an article by the American Medical Association, an investigation found that by allowing approval for high-risk medical devices without sufficient testing through an FDA streamlined pathway, tens of thousands of injuries and deaths occurred. Yet this has not been the case for the Graduated Electronic Decelerator (GED), the skin shock device which saved my brother's life, stopped his life-threatening head banging, and has been safe. As I have stated before, I tried the device myself because I wanted to experience what my brother experienced. Medical decisions need to be based on facts, scientific evidence, not emotional arguments.