Submit MDUFA comments from public stakeholders.
Federal Register announcement of 3/28/12 MDUFA meeting
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!
Twitter: @JjrkCh
Wednesday, March 21, 2012
Public stakeholders (you!) speak out about medical device safety.
Labels:
adverse events,
arthroplasty,
ASR hip,
Congress,
ePatient,
FDA,
IOM,
joint replacement,
medical devices,
patient safety,
post-market data,
product recall,
revision surgery,
surgical mesh
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