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. It is reauthorized every 5 years.
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.
History + Medical Device User Fee and Modernization Act legislative history 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
User fees + User Fees for FY 2024 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
References
External links , FDA