Eye on the FDA

October 29, 2009 by MassDevice

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.
August 2010 Special
Download the report free of charge for the month courtesy of Clinquest by using the discount code: clinquest

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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