US Device User-Fee Rates Will Drop About 10.3% In Fiscal 2017

01 Aug 2016

• By Sue Darcey

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.

Device sponsors will pay about 10.3% less in user fees to submit their PMA and 510(k) applications, and other submissions to the US FDA in fiscal year 2017, compared to FY 2016 fee rates.

Companies will also see about a 12% reduction in the annual establishment registration fee in the upcoming fiscal year beginning...