Medical Device User Fee and Modernization Act

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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]

History

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Medical Device User Fee and Modernization Act legislative history[1]
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

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User Fees for FY 2024[3][4]
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

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  1. ^ a b c "MDUFA V" (PDF). Biocom California. Feb 2023. Retrieved 16 April 2024.
  2. ^ "Background on MDUFMA". FDA. July 9, 2016. Retrieved 16 April 2024.Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ Health, Center for Devices and Radiological (September 29, 2023). "Medical Device User Fee Amendments (MDUFA)". FDA. Retrieved 16 April 2024.Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ "Medical Device User Fee Rates for Fiscal Year 2024". Federal Register. Retrieved 16 April 2024.
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