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 |