The US Food and Drug Administration (FDA) is kicking off the reauthorization process for the Medical Device User Fee Act (MDUFA), a program which funds a significant portion of its medical device regulatory review activities.
Background
FDA's user fee program began with the passage of the Prescription Drug User Fee Act (PDUFA) in 1992. The law, originally intended to speed up the regulatory review process, wound up being so popular that it inspired several other user fee programs, including MDUFA.
MDUFA was passed into law in 2002 under the Medical Device User Fee and Modernization Act (MDUFMA), and subsequently reauthorized in 2007 under the FDA Amendments Act (FDAAA) and 2012 under the FDA Safety and Innovation Act (FDASIA).
The most recent iteration, known as MDUFA III, was intended to dramatically increase the funding for FDA's Center for Devices and Radiological Health (CDRH) in return for improvements to review times for medical devices.
| FY15 MDUFA User Fees |
|---|
| Application Type | Standard Fee | Small Business Fee |
| 510(k) | $5,018 | $2,509 |
| 513(g) | $3,387 | $1,694 |
| PMA, PDP, PMR, BLA | $250,895 | $62,724 |
| Panel-track supplement | $188,171 | $47,043 |
| 180-day supplement | $37,634 | $9,409 |
| Real-time supplement | $17,563 | $4,391 |
| BLA efficacy supplement | $250,895 | $62,724 |
| Annual report | $8,781 | $2,195 |
| 30-day notice | $4,014 | $2,007 |
Review times for Premarket Approval Applications (PMAs), used in the submission of high-risk devices, and premarket notifications [510(k)s], used in the submission of lower-risk devices, had been lagging significantly since MDUFA II was signed into law.
-Review-Times.jpg "510(k) Review Times")
New Reauthorization Struggle
Those same issues—the speed at which FDA is reviewing new medical technologies and the return industry is getting for its considerable investment (i.e. user fees) into FDA—are almost certain to be some of the biggest concerns during the upcoming reauthorization process for MDUFA IV.
FDA is now set to hold its first public meeting on that reauthorization process on 13 July 2015, it announced this week.
The reauthorization process is controlled in part by federal legislation, the Federal Food, Drug and Cosmetic Act, Section 738A of which requires FDA to request "public input on the reauthorization" prior to starting any negotiations with industry.
In addition, FDA is required to hold a public meeting, during which time the public may comment on the reauthorization process and recommend changes to be made to the upcoming user fee agreement.
While FDA has not yet published the questions it plans to ask at the meeting, based on the agency’s other user fee programs, two questions are likely to be asked:
- What is your assessment of the overall performance of the MDUFA program to date?
- What aspects of MDUFA should be retained, changed or discontinued to further strengthen and improve the program?
The authorization for the current user fee agreement expires in September 2017.
FDA Announcement