The U.S. Food and Drug Administration (FDA) has announced user fees applicable to medical device applications for Fiscal Year (FY) 2019.
Published in late August in the Federal Register, the new fees will represent a modest increase for many medical device manufacturers, especially when compared with the increase in fees for FY 2018 over FY 2017. To illustrate, the standard fee for 510(k) applications in FY 2019 will be $10,953, a 3.66 percent increase over the $10,566 charged during FY 2018. The FY 2018 fee for 510(k) applications represented a more than 100 percent increase over the $4670 fee applicable in FY 2017.
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 $2738, a 3.63 percent increase over the $2642 charged in FY 2018. 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.
