US medical device user fee rates are increasing in FY 2018, in some cases significantly, under the newly reauthorized MDUFA IV, but small businesses are given more cushion.
US FDA Fees To Spike In FY 2018, But Small Firms Get Breaks
The standard US FDA fee for a 510(k) submission will increase 124% in FY 2018, but small companies will see a much more moderate 12% jump. Other fees will increase by between 30%-40% in the coming fiscal year. And, perhaps, the biggest change will be for de novo submissions, which will have a user fee for the first time. FDA issued its inflation-adjusted user-fee schedule following the recent enactment of MDUFA IV.
