FDA Releases Device User Fees for FY 2019

July 30, 2018

The FDA announced MDUFA IV user fees for fiscal 2019 with modest increases that will go into effect on Oct.1.

For pre-market applications, product development protocols or biologics license applications, the standard fee will be $322,147, up from $310,764 for fiscal 2018. Small businesses will pay $80,537 compared with $77,691 in fiscal 2018. The same fees apply for premarket reports and efficacy supplements.

The standard and small business fees for 510(k) premarket notification submissions will be $10,953 and $2,738, respectively, while de novo classification requests will be $96,644, with a $24,161 fee for small businesses.

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