The Medical Device User Fee and Modernization Act (MDUFA) authorizes the Center for Devices and Radiological Health (CDRH) to collect user fees from medical device manufacturers. [1] It is reauthorized every 5 years. [1]
In the years preceding enactment of MDUFMA, the FDA's medical device program suffered a long-term, significant loss of resources that undermined the program's capacity and performance. [2]
Year | Act | Legislative Package | Synopsis |
---|---|---|---|
2002 | MDUFA | Authorized FDA to collect fees for premarket review | |
2007 | MDUFA II | FDA Amendments Act of 2007 | Added two types of annual fees: establishment registration fee and product fee |
2012 | MDUFA III | Safety and Innovation Act of 2012 | Expanded the definition of establishments subject to a registration fee, thus increasing the applicable device establishments paying the fee. |
2017 | MDUFA IV | FDA Reauthorization Act of 2017 | Advanced the utilization of real-world evidence and patient engagement |
2022 | MDUFA V | Continuing Appropriations and Ukraine Supplemental Appropriations Act |
Application Type | Standard Fee | Small Business Fee |
---|---|---|
510(k) | $21,760 | $5,440 |
513(g) | $6,528 | $3,264 |
PMA, PDP, PMR, BLA | $483,560 | $120,890 |
De Novo Classification Request | $145,068 | $36,267 |
Panel-track Supplement | $386,848 | $96,712 |
180-Day Supplement | $72,534 | $18,134 |
Real-Time Supplement | $33,849 | $8,462 |
BLA Efficacy Supplement | $483,560 | $120,890 |
30-Day Notice | $7,737 | $3,869 |
Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $16,925 | $4,231 |
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