The FDA said it will hold a public meeting in the coming weeks to discuss the IOM recommendations, part of a report titled, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.”
The report said the 510(k) process could not promote innovation, ensure effectiveness and review devices in a timely fashion because the process is “fundamentally at odds” with federal statutes on the process, the report said.
Read the FDA release seeking comment on the device approval process.
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