The FDA has begun to ask for public comment on the Institute of Medicine's recommendations to overhaul the 510(k) approval process for medical devices, according to an FDA release.
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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