While a recent FDA-commissioned report by the Institute of Medicine proposes scrapping the review standards and starting fresh, the modifications suggest the agency prefers keeping the standards and tweaking them.
The new proposed standards, reported in the Federal Register, would be used to support 510(k) applications by demonstrating “reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices.”
Read the Federal Register notice on proposed FDA modifications for reviewing device applications.
Related Articles on the FDA’s 510(k) Reviews for Medical Devices:
FDA Seeking Comment on IOM Device Recommendations
OM Calls for Overhaul of FDA Device Approval Process; MDMA Disagrees
FDA Specifies When Existing Devices Need New 510(k) Process
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