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 use 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 |