Most Premarket Applications Will See 7% Increase Next Year
The US FDA has bumped up the cost of filing for a premarket application in fiscal year 2021 by roughly 7%. That’s slightly higher than the user fee increases under MDUFA IV last year.
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The COVID-19 crisis had already forced the US FDA to postpone its first public meeting on the medical device user-fee negotiations to early next May, which was to be webcast. Now the agency has postponed the meeting indefinitely.
Most categories of medical device user fee applications will be 6% more expensive starting in October. Establishment registration fees will see more than a 7% increase as well, regardless of whether a company is considered a small business.
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.