The U.S. Food and Drug Administration (FDA) has announced user fees applicable to medical device applications for Fiscal Year (FY) 2018.
Published in late August in the Federal Register, the new fees will represent a significant increase for many medical device manufacturers. For example, the standard fee for 510(k) applications will be $10,566, more than double the $4690 fee applicable in FY 2017. Other registration fees applicable to most companies will increase an average of 33 percent.
Registration fee increases are less for those companies that have been qualified as small businesses. For those companies, the fee for a 510(k) application will be $2642, a 13 percent increase over FY 2017.
To qualify for small-business status and reduced fees under the FDA’s fee structure, a company must have annual sales of not more than $100 million. Further discounts or a complete waiver of some fees may be available to those companies with annual sales of $30 million or less.
The new fees are applicable to all medical device applications filed as of October 1, 2017. See a list of the new fees as published in the Federal Register.