On 7/29/11 the Institute of Medicine concluded a 22 month study (commissioned by HHS Health and Human Services) stating that the 510(k) process of approving implanted medical devices is flawed and should be abandoned. The medical device industry and the bureaucracy of FDA is resisting updating the regulations that are 35 years OLD.
This is a personal story of the medical and legal purgatory awaiting the unfortunate percentage of patients in which implanted medical devices fail.
This is a very important video. I'm sorry your brother Steven is going through this.
hugooc 4 months ago