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.
Related Articles on the Institute of Medicine Report on the FDA Device Approval Process:
Group Says Upcoming Device Report Will be Biased
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.