FDA Device Fees and Approvals Up, Review Times Down

Medical device companies paid the FDA $96.8 million in user fees during fiscal year 2013, up 48% from the previous year.

What is industry getting for that extra money? For one thing, according to an agency quarterly report, the percentage of premarket approval (PMA) applications approved by the agency grew from 59% in 2010 to 74% so far in 2014. The average time to get a decision for a PMA has dropped over 30% from a high of 464 days in 2009 to 297 in 2012. The agency has also decreased the PMA backlog by over 45% from 92 in 2010 to 49 in 2014.

In addition to more PMA approvals, FDA Commissioner Margaret Hamburg, M.D., reported on the FDA blog that review times for 510(k) clearances have declined, with nearly all of 2012 submissions now closed. The average review times for a 501(k) clearance dropped from a high of 154 days in 2010 to 144 days in 2012.

The big jump in fees was due to a new Medical Device User Fee Act (MDUFA III) that went into effect this past year. There was an equally significant jump in user fees in 2007 when the first MDUFA period closed and MDUFA II went into effect. That year, user fees increased 65.5%, according to the report, but FDA performance got worse.

Under MDUFA III with the device industry, the FDA will collect almost $600 million in fees over five years. The agency plans to hire an additional 200 full-time employees over that time to speed up review times. Hamburg told Congress recently that since October 1, 2013, the agency has already hired 90 of those employees.

The agency is required to submit a quarterly report on performance under the new user device agreement. To read the latest report presented on April 29, 2014, click here:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM395834.pdf