Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FY 2011 user fees: FDA publishes device user fee rates for fiscal year 2011 in an Aug. 3 Federal Register 1notice. The rates increase by about 8.5% each year, as required by statute. The FY 2011 standard fee for a pre-market approval (PMA) application is $236,298, or $59,075 for small businesses. 510(k) submission fees are $4,348, or $2,174 for small businesses. All establishments must pay a $2,179 annual registration fee, with no discount for small businesses. The updated fees apply to applications received from Oct. 1, 2010, through Sept. 30, 2011