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

 
• 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.

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