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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.

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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.

On Aug. 28, US FDA released its final medical device user fee schedule for FY 2018, which begins in October. The rates are based on the MDUFA IV agreement reached...

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