US Device User-Fee Rates Will Drop About 10.3% In Fiscal 2017
Standard US FDA medical device user-fee rates will go down by about 10.3% for PMAs and 510(k)s for fiscal year 2017 beginning Oct. 1. User-fee rates are calculated based on statutory FDA revenue targets adjusted by inflation and "excess" fees collected in prior years.
You may also be interested in...
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.
While Congress makes its push to reauthorize US FDA user fees by mid-summer, here are 10 important details from the underlying industry-agency user-fee agreements that medtech firms should know.
Omnibus legislation to fund the federal government for the remainder of FY 2017 includes a switch from what has been a growing trend of FDA's increasing reliance on industry user fees as opposed to congressional appropriations. Non-user-fee budget authority will grow, while fee amounts dropped for the fiscal year.