Table I. Medical device user fees for FY 2011.

FDA has announced the user fee rates for FY 2011. Federal law stipulates that the fee rate for each submission type is set at a specified percentage of the standard fee for a premarket approval (PMA) application. For FY 2011, the PMA standard fee is $236,298, an 8.5% increase from FY 2010. All fees for FY 2011 apply from October 1, 2010, through September 30, 2011.

Under the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee Amendments of 2007), the agency has the power to collect user fees for registered establishments and medical device submissions as well as annual fees for certain periodic reports.

Companies that qualify as a small business pay reduced fees in some instances. For example, small businesses only pay $59,075 for PMA applications. To qualify, a company must have gross receipts or sales of no more than $100 million for the most recent tax year. Those that earn less than $30 million may also have their first premarket application fee waived. However, there is no reduction for the establishment registration fee (see Table I)