Increase medical device implant patient protections and industry accountability by changing the charter of the FDA to comply with IOM 7/29/11 report on the flawed FDA 510(k) process.
Why is this important?
The Institute of Medicine on 7/29/11 reported that the FDA process of clearing implanted medical devices for the U.S. market is fatally flawed and should be scrapped. Joint replacement is now the #1 expenditure of Medicare. The FDA charter must be updated from the 1976 OLD version to provide substantially greater safeguards for patients.
