Eye on the FDA, H1 2009
October 29, 2009 by MassDevice
A semi-annual report on the Food & Drug Administration's 510(k) approval process
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.
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