Medical Device User Fee and Modernization Act
(Redirected from MDUFMA I)
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
[edit]| 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
[edit]| 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
[edit]- ^ a b c "MDUFA V" (PDF). Biocom California. Feb 2023. Retrieved 16 April 2024.
- ^ "Background on MDUFMA". FDA. July 9, 2016. Retrieved 16 April 2024.
This article incorporates text from this source, which is in the public domain.
- ^ Health, Center for Devices and Radiological (September 29, 2023). "Medical Device User Fee Amendments (MDUFA)". FDA. Retrieved 16 April 2024. This article incorporates text from this source, which is in the public domain.
- ^ "Medical Device User Fee Rates for Fiscal Year 2024". Federal Register. Retrieved 16 April 2024.
External links
[edit]- Official website, FDA
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