FDA: 2023 Medical Device User Fees Announcement
Medical device user fees for the Fiscal Year 2023 are now available following an announcement from the U.S. Food and Drug Administration (FDA). The fiscal year runs from October 1, 2022 – September 30, 2023. All medical device facilities must pay the new fee amounts to keep their FDA status.
The increment takes effect from the beginning of FDA’s 2022 fiscal year (FY 2022) from October 1, 2021 to September 30 2022. However, Premarket approval applications have to be submitted before September 30, 2021.
How does this latest MDUFA affect small businesses?
FDA continues to discount certain fees for small businesses. Small businesses in this case being businesses with sales under $100 million annually.
While there are waivers and fee reduction of other types of fees for small businesses, there is none for establishment registrations. Establishment registration is the same for all applicants, regardless of the size of the business.
Establishment registration for FY 2022 is $5,672 across the board.
Standard and small Business Application Fees for FY 2023
Application Types | Standard Fees | Small Business Fees |
510(k) | $12,745 | $3,186 |
513(g) | $5,061 | $2,530 |
Premarket Approval | $374,858 | $93,714 |
De Novo | $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 |
PMA Annual Reporting on a Class III device | $13,120 | $3,280 |
How does FY 2022 compare to FY 2021?
Compared to the 2021 fiscal year which saw a fee increase of 7% from the previous year, the 2022 plan is much more agreeable. With the exception of the annual establishment registration fee which was $5,546 across board, here are the fees for the concluding FY 2021.
Standard and small Business Application Fees for FY 2021
Application Type | Standard Fee | Small Business Fee |
510(k) | $12,432 | $3,108 |
513(g) | $4,936 | $2,468 |
PMA | $365,657 | $91,414 |
De Novo | $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 |
PMA Annual Reporting on a Class III device | $12,798 | $3,200 |
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