The U.S. Food and Drug Administration (FDA) plans to reduce medical device user fees by 7% next year, while at the same time starting a program to offer discounted rates for small medical device firms.
In an August 1 announcement, the agency proposed an annual user fee of $2,029 in 2012 for medical device companies, compared with $2,179 this year. The fee for a 510(k) submission would be $4,049 next year, compared with $4,348 in 2011.
Premarket approval (PMA) applications will cost $220,050 in 2012, compared with $236,298 this year. Small businesses will be required to pay $55,013 next year, compared with $59,075 this year.
Small businesses also may qualify for discounted rates and a one-time waiver of the fee for their first-ever premarket application.
