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]

Contents

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

Medical Device User Fee and Modernization Act legislative history [1]
YearActLegislative packageSynopsis
2002MDUFAAuthorized FDA to collect fees for premarket review
2007MDUFA IIFDA Amendments Act of 2007Added two types of annual fees: establishment registration fee and product fee
2012MDUFA IIISafety and Innovation Act of 2012Expanded the definition of establishments subject to a registration fee, thus increasing the applicable device establishments paying the fee.
2017MDUFA IVFDA Reauthorization Act of 2017Advanced the use of real-world evidence and patient engagement
2022MDUFA VContinuing Appropriations and Ukraine Supplemental Appropriations Act

User fees

User Fees for FY 2024 [3] [4]
Application typeStandard feeSmall-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

  1. 1 2 3 "MDUFA V" (PDF). Biocom California. Feb 2023. Retrieved 16 April 2024.
  2. ↑ "Background on MDUFMA". FDA. July 9, 2016. Retrieved 16 April 2024.PD-icon.svg 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.PD-icon.svg 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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