FDA user fee estimator
Estimate your FDA medical device user fee for the current fiscal year. Companies with $100M or less in gross receipts, including affiliates and companies outside the U.S., can qualify for reduced small business fees.
Small business status must be requested before the fee is due and renewed each fiscal year. Foreign companies need a certification from their national tax authority. We can help.
Estimates only. Fees are set annually by FDA; confirm current amounts with FDA before paying.