Eye on the FDA: Full-year 2009
This investigation of 2009 510(k) clearances for medical devices by the Food & Drug Administration shows that times to clearance continue to rise, even as the number of clearances granted falls.
Eye on the FDA: H1 2009
This investigation of 10 years of Food & Drug Administration data on its 510(k) approval process for medical devices shows that the approval time for medical devices increased nearly 2 percent — while the number of 510(k) applications declined more than 19 percent — even as the FDA’s budgets and staff levels rose.
Click here for an executive summary of the report.