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 2015 | FY 2014 | FY 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.