Devicemakers See Lower Fees in MDUFA 2017

Devicemakers will pay almost $27,000 less for premarket applications for medical device user fees in fiscal year 2017.

The new fees go into effect Oct. 1 through Sept. 30, 2017. Companies will need to pay the correct fee when they submit applications or they risk having their applications rejected, the agency said in its July 28 notice. The statute authorizes the FDA to collect $140.762 million in user fees.

Similar to the fee structures announced for PDUFA, GDUFA and BsUFA, the FDA’s MDUFA fees are slightly lower across the board for FY 2017 compared to FY 2016. — Tamra Sami