Medical Device US FDA user fees were first settled in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). User fees were restored in 2007, with the Medical Device User Fee Amendments to the FDA Amendments Act (MDUFA II), in 2012 with the Medical Device User Fee Amendments to the FDA Safety and Innovation Act (MDUFA III), and in 2017 with the Medical Device User Fee Amendments to the FDA Reauthorization Act (MDUFA IV). MDUFA IV will be set up from Oct. 1, 2017, until Sept. 30, 2022.
Under the user fees framework, medical devices organizations pay fees to the FDA when they register their foundations and list down their devices with the agency, at whatever point they present an application or a notice to market another medicinal device in the U.S. what’s more, for certain different sorts of entries. These fees help the FDA increase the proficiency of regulatory procedures with an objective of lessening the time it takes to carry safe and effective medical devices to the U.S. market.
MDUFA Updated Their User Fees for FY2024
Annual Establishment Registration Fee: $7,653
- There are no waivers or reductions for small establishments, businesses, or groups in FY 2024.
- Other fees for Fiscal Year 2024 (October 1, 2023, through September 30, 2024) are:
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 |
MDUFA updated their User Fees for FY2023
Annual Establishment Registration Fee: $6,493
- There are no waivers or reductions for small establishments, businesses, or groups.
- The annual establishment registration fee must be paid between October 1, 2022, and December 31, 2022.
The updated fees structure is as follows
Application Type | Standard Fee | Small Business Fee† |
510(k) | $19,870 | $4,967 |
513(g) | $5,961 | $2,980 |
PMA, PDP, PMR, BLA | $441,547 | $110,387 |
De Novo Classification Request | $132,464 | $33,116 |
Panel-track Supplement | $353,238 | $88,309 |
180-Day Supplement | $66,232 | $16,558 |
Real-Time Supplement | $30,908 | $7,727 |
BLA Efficacy Supplement | $441,547 | $110,387 |
30-Day Notice | $7,065 | $3,532 |
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs) | $15,454 | $3,864 |
For any query or questions related to this you can contact us .. we are also sharing the previous structure .
User Fees for FY2022
Annual Establishment Registration Fee: $5,672
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.
Other fees for Fiscal Year 2022 (October 1, 2021 through September 30, 2022) are:
| Application Type | Standard Fee | Small Business Fee† |
| 510(k) | $12,745 | $3,186 |
| 513(g) | $5,061 | $2,530 |
| PMA,PDP,PMR,BLA | $374,858 | $93,714 |
| De Novo Classification Request | $112,457 | $28,114 |
| Panel-track Supplement | $281,143 | $70,286 |
| 180-Day Supplement | $56,229 | $14,057 |
| Real-Time Supplement | $26,240 | $6,560 |
| BLA Efficacy Supplement | $374,858 | $93,714 |
| 30-Day Notice | $5,998 | $2,999 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $13,120 | $3,280 |
FY 2021 US FDA User Fees (in .US. Dollars)
The fees for fiscal year 2021 (October 1, 2020 through September 30, 2020) are as follows:
| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k)‡ | $12,432 | $3,108 |
| 513(g) | $4,936 | $2,468 |
| PMA, PDP, PMR, BLA | $365,657 | $91,414 |
| De Novo Classification Request | $109,697 | $27,424 |
| Panel-track Supplement | $274,243 | $68,561 |
| 180-Day Supplement | $54,849 | $13,712 |
| Real-Time Supplement | $25,596 | $6,399 |
| BLA Efficacy Supplement | $365,657 | $91,414 |
| 30-Day Notice | $5,851 | $2,926 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) | $12,798 | $3,200 |
‡ Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.
Annual Establishment Registration Fee: $5,546
There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.
Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.
Additional Information Medical Device User Fee Small Business Qualification and Certification: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (/regulatoryinformation/search-fda-guidance-documents/medical-device-user-fee-small-businessqualification-and-certification)
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Source / Read More: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
