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 Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
  2. ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
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