Eye on the FDA
MassDevice's "Eye on the FDA" report examines key data on the FDA's 510(k) approvals process on a semi-annual basis, analyzing the approvals according to medical discipline, approval times and a variety of other categories. The reports characterize changes in the number of 510(k) approvals and decision times, identifying the most active medical disciplines and states and offering perspectives on approval trends and developments in the regulatory landscape.
Eye on the FDA
October 29, 2009 by MassDevice
A semi-annual report on the Food & Drug Administration's 510(k) clearance process
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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