FDA's user fees not a sure win for medical devices | On Call

Fri, 07/13/2012 - 10:05am
Mass Device

Despite promises of increased speed and efficiency in medical device review pathways, the FDA's increased user fees aren't a guarantee of improvement.

MassDevice On Call

MASSDEVICE ON CALL — Medical device makers may still have a way to go in ensuring the increased speed and efficiency they were promised when they signed off on the latest iteration of the FDA's user fee program.

The program, which began in 2003 has returned "mixed results," according to Forbes writer John Graham, who conducted an analysis for the Pacific Research Institute of the FDA's expanded budget and subsequent changes in productivity.

Despite increased funding, the FDA's processes may have become less productive, Graham wrote.


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