Medical Device User Fees Set to Drop in 2015, But Not by Much

Posted 30 July 2014 | By Alexander Gaffney, RAC 

Medical Device User Fees Set to Drop in 2015, But Not by Much

The US Food and Drug Administration (FDA) has announced the fees it plans to charge manufacturers of medical device products in Fiscal Year (FY) 2015 under the Medical Device User Fee (MDUFA) program.

The fees, which were updated in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), are collected by FDA and used to hire additional review staff and make other improvements at the agency meant to speed up device review times.

Under FDASIA, all FDA user fees—including those for devices—are adjustable, which is intended to make sure FDA's funding is able to take into account variables like inflation, payroll expenses and the number of device submissions.

And in the coming year, medical device manufacturers will have a rare surprise: The fees they are expected to pay will actually decrease, albeit slightly.

Medical Device User Fee Act (MDUFA): FY 2013-2015 User Fees

 FY 2015FY 2014FY 2013
Premarket Application$250,895$258,520$248,000
Product Development Protocol$250,895$258,520$248,000
Biologics Licensing Application$250,895$258,520$248,000
Premarket Report$250,895$258,520$248,000
BLA Efficacy Supplement$250,895$258,520$248,000
Panel-Track Supplement$188,171$193,890$186,000
180-Day Supplement$37,634$38,778$37,200
Real-Time Supplement$17,563$18,096$17,360
510(k) Premarket Notification Submission$5,018$5,170$4,960
30-Day Notice$4,014$4,136$3,968
513(g) Request for Classification Information$3,387$3,490$3,348
Annual Fee for Class III Device$8,781$9,048$8,680
Annual Establishment Registration$3,646$3,313$2,575

As in past years, fee reductions and waivers are available for first-time filers and small businesses.


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