September 22, 2011 FDA/CDRH Town Hall mtg. in San Francisco
This is an opportunity for the public to attend and support consumer/taxpayer/patient rights in determining how FDA follows up on the IOM 7/29/11 report stating that the 510(k) process is flawed.
Implanted medical devices must be safe and effective: not just "innovative". If you cannot come, please write to :
Dr. Jeffrey Shuren
Food and Drug Administration (FDA)
9200 Corporate Boulevard
Rockville MD 20859
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.
Please share what you have learned!