The U.S. Food and Drug Administration (FDA) plans to increase its medical device user fees by 8.5%, effective October 1.
For the 2011 fiscal year, the standard fee for a 510(k) application will be $4,348, up from $4,007 charged during the 2010 fiscal year (end-September 30). The small-business fee will be $2,174, compared with $2,004 required during the 2010 fiscal year.
The standard fee for a premarket approval (PMA) application will become $236,298, up from $217,787 charged this year. The small-business fee for a PMA will be $59,075, compared with $54,447 in fiscal 2010.
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