The Institute of Medicine 7/29/11 reports that the FDA system is flawed.
HHS/FDA (Health and Human Services & the Food and Drug Administration) asked the objective Institute of Medicine to review the process that FDA uses to clear medical devices for the U.S. market. The review took 22 months.
Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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