2024-16883. Medical Device User Fee Rates for Fiscal Year 2025

Table 1—FDA PC&Bs Each Year and Percent Change

	FY 2021	FY 2022	FY 2023	3-Year average
Total PC&B	$3,039,513,000	$3,165,477,000	$3,436,513,000
Total FTE	18,501	18,474	18,729
PC&B per FTE	$164,289	$171,348	$183,486
Percent change from previous year	0.1811%	4.2967%	7.0838%	3.8539%

The payroll adjustment is 3.8539 percent multiplied by 60 percent, or 2.3123 percent. The statute specifies that the component of the inflation adjustment for non-payroll costs for FY 2025 is the average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally Adjusted; All Items; Annual Index) for the first 3 of the preceding 4 years of available data multiplied by 0.40, or 40 percent (see section 738(c)(2)(C)(i)(II) of the FD&C Act).

Table 2 provides the summary data and the 3-year average percent change in the specified CPI for the Washington-Arlington-Alexandria area. These data are published by the Bureau of Labor Statistics and can be found on their website under series Id CUURS35ASA0 at: https://data.bls.gov/​pdq/​SurveyOutputServlet?​data_​tool=​dropmap&​series_​id=​CUURS35ASA0,CUUSS35ASA0.

Table 2—Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI

	2021	2022	2023	3-Year average
Annual CPI	277.728	296.117	305.317
Annual Percent Change	3.9568%	6.6212%	3.1069%
3-Year Average Percent Change in CPI				4.5616%

The non-payroll adjustment is 4.5616 percent multiplied by 40 percent, or 1.8246 percent. Next, the payroll adjustment (2.3123 percent or 0.023123) is added to the non-payroll adjustment (1.8246 percent or 0.018246), for a total of 4.1369 percent (or 0.041369). To complete the inflation adjustment, 1 (100 percent or 1.0) is added for a total base inflation adjustment of 1.041369 for FY 2025. If the base inflation adjustment for a fiscal year is greater than 1.04, such adjustment shall be considered to be equal to 1.04 (see section 738(c)(2)(C)(ii)(II) of the FD&C Act). The total base inflation adjustment for FY 2025 is 1.04.

MDUFA V provides for this inflation adjustment to be compounded for FY 2023 and each subsequent fiscal year (see section 738(c)(2)(B) of the FD&C Act). To complete the compounded inflation adjustment for FY 2025, the FY 2024 compounded adjustment (1.079318) is multiplied by the FY 2025 base inflation adjustment (1.040000) to reach the applicable inflation adjustment of 1.122491 (rounded) for FY 2025. We then multiply the total revenue amount for FY 2025 ($350,746,400) by 1.122491, yielding an inflation adjusted total revenue amount of $393,710,000 (rounded to the nearest thousand dollars).

III. Adjustments to Base Fee Amounts for FY 2025

Under the FD&C Act, all submission fees and the periodic reporting fee are set as a percent of the standard (full) fee for a premarket application (see section 738(a)(2)(A) and (b)(1) of the FD&C Act).

A. Inflation Adjustment

MDUFA specifies that the base fees of $445,000 (premarket application) and $7,100 (establishment registration) are to be adjusted for FY 2025 using the same methodology as that for the total revenue inflation adjustment in section II (see section 738I(2)(D)(i) of the FD&C Act). Multiplying the base fees by the compounded inflation adjustment of 1.122491 yields inflation adjusted base fees of $499,508 (premarket application) and $7,970 (establishment registration).

B. Further Adjustments To Generate the Inflation-Adjusted Total Revenue Amount

After the applicable inflation adjustment to fees is done, FDA may increase, if necessary to achieve the inflation adjusted total revenue amount, the base fee amounts on a uniform proportionate basis (see section 738(c)(2)(D)(ii) of the FD&C Act). After this adjustment, if necessary, FDA may further increase the base establishment registration fees to generate the inflation-adjusted total revenue amount (see section 738(c)(3) of the FD&C Act).

For FY 2025, further adjustments were required to meet the inflation adjusted total revenue amount of $393,710,000. After increasing base fees, on a uniform proportionate basis, and further increasing establishment registration fees, this yields inflation adjusted base fees of $540,783 (premarket application) and $8,716 (establishment registration).

C. MDUFA V Adjustments Solely to Registration Fees

MDUFA V has three new potential adjustments that will not change the total revenue amount but may impact collections by increasing or decreasing establishment registration base fees only. These adjustments are the performance improvement adjustment, the hiring adjustment, and the operating reserve adjustment.

1. Performance Improvement Adjustment

Beginning with FY 2025, this adjustment allows FDA to collect fees in addition to the total revenue amount in FYs 2025, 2026, and 2027, if the Agency meets certain performance goals in FYs 2023, 2024, and 2025. If applicable, this provision further increases base establishment registration fee amounts to achieve an increase in total fee collections equal to the applicable performance improvement adjustment, which is set forth in the statute (see section 738(c)(4) of the FD& C Act). FDA met the FY 2023 Pre-Submission Written Feedback goal, which triggers the performance improvement adjustment for FY 2025.

For FY 2025, the performance improvement adjustment is equal to the product of the pre-submission amount in section 738(c)(4)(B)(i)(I) of the FD&C Act, $15,396,600, and the inflation adjustment under section 738(c)(2)(B) of the FD&C Act, 1.122491. See section 738(c)(4)(A)(i) of the FD&C Act. For FY 2025, the performance improvement adjustment is $17,282,545.

2. Hiring Adjustment

Beginning with FY 2025, this adjustment provides for the reduction of base establishment registration fees in FYs 2025, 2026, and 2027, if specified hiring goals for FYs 2023, 2024, and 2025 are not met by a certain threshold. The hiring adjustment would serve to decrease the base establishment registration fee amounts, as necessary, to achieve a reduction in total fee collections equal to the hiring adjustment amount, which is set forth in the statute (see section 738(c)(5) of the FD&C Act).

FDA met the FY 2023 statutory hiring threshold of 123 hires, so establishment registration fees will not need to be lowered by the hiring adjustment amount in FY 2025. Since FDA met the FY 2023 Pre-Submission Written Feedback goal, the FY 2027 statutory hiring goal will be 83 hires for fiscal year 2025 (see section 738(c)(5)(D)(iii)(II) of the FD&C Act) and the threshold will be 75 hires for fiscal year 2025 (see section 738(c)(5)(B)(iii)(II) of the FD&C Act).

3. Operating Reserve Adjustment

For FYs 2023 to 2027, the operating reserve adjustment requires FDA to decrease base establishment registration fees if the amount of operating reserves of carryover user fees exceeds the “designated amount”, and such reduction is necessary to provide for not more than such designated amount of operating reserves of carryover user fees (see section 738(c)(6)(A) of the FD&C Act). In making this calculation for FYs 2023 to 2026, a certain amount is excluded from the designated amount and is not subject to the decrease (see section 738(c)(6)(C) of the FD&C Act). For FY 2025, this excluded amount is $77,496,161.

The designated amount is equal to the sum of 13 weeks of operating reserves of carryover user fees plus 1 month of operating reserves, as described in 738(c)(8) (see 738(c)(6)(B) of the FD&C Act).

To determine the 13-week operating reserves of carryover user fees amount, the FY 2025 inflation-adjusted total revenue amount (from section II), $393,710,000, is added to the inflation-adjusted performance improvement adjustment amount (from section III.C.1), $17,282,545, resulting in $410,992,545. This amount is then divided by 52, and then multiplied by 13. The 13-week operating reserve amount for FY 2025 is $102,748,136.

To determine the 1 month of operating reserves described in section 738(c)(8) of the FD&C Act, the FY 2025 inflation-adjusted total revenue amount of $393,710,000 is added to the inflation-adjusted performance improvement adjustment amount of $17,282,545, resulting in $410,992,545. This amount is then divided by 12. The 1 month of operating reserves for FY 2025 is $34,249,379.

For FY 2025, the designated amount is equal to the 13-week operating reserve of $102,748,136 plus the 1 month of operating reserves of $34,249,379, totaling $136,997,515.

To determine the FY 2024 end-of-year operating reserves of carryover user fees amount, FDA combined the actual collections and obligations at the end of the third quarter (June 2024) and added the forecasted collections and obligations for the fourth quarter of FY 2024 to generate a full year estimate for FY 2024. The estimated end-of-year FY 2024 operating reserves of carryover user fees is $50,394,972 (Note, this amount includes the 1-month reserve).

Note that under MDUFA V, for the purposes of calculating the operating reserve adjustment, this amount does not include user fee funds considered unappropriated ($26,680,243) or unearned revenue ($62,498,454). In addition, as noted above, for purposes of the operating reserve adjustment, operating reserves of carryover user fees do not include the estimated $77,496,161 remaining to spend at the end of FY 2024 from the total of $118,000,000 intended to support the Total Product Life Cycle Advisory Program Pilot and Third-Party Review programs.

Because the estimated end-of-year FY 2024 MDUFA operating reserves of carryover user fees amount totaling $50,394,972 does not exceed the FY 2025 designated amount of $136,997,515, FDA will not decrease the base establishment registration fee amounts for FY 2025 to provide for not more than such designated amount.

As there is a performance improvement adjustment for FY 2025, but no hiring adjustment or operating reserve adjustment, establishment registration fees are increased to achieve an increase in total fee collections for FY 2025 equal to the performance improvement adjustment amount of $17,282,545. After so increasing establishment registration fees only, this yields fees of $540,783 (premarket application) and $9,280 (establishment registration).

IV. Calculation of Fee Rates

As noted in section II, the total revenue amount after the applicable inflation adjustment is $393,710,000 (rounded to the nearest thousand dollar). As noted in section III, the performance improvement adjustment solely to registration fees for FY 2025 is $17,282,545. There is no hiring adjustment or operating reserve adjustment for FY 2025.

Table 3A provides fee-paying submission counts, excluding establishment registration, for the last 3 years and the 3-year average. Table 3B provides establishment registration fee-paying submission counts for the most recently completed fiscal year (FY 2023). Historically, FDA has estimated the total number of fee-paying submission counts it expects to receive during the next fiscal year by averaging the number of fee-paying submission counts received in the 3 most recently completed fiscal years; for FY 2025 fee-setting, this would be an average of FY 2021 through FY 2023. FDA received an abnormally high volume of fee-paying establishment registrations due to the COVID-19 pandemic in FY 2020 and FY 2021. The surge in fee-paying establishment registrations has been declining starting in FY 2022, trending back toward pre-pandemic levels. In an effort to normalize the projected volume of establishment registration submissions for the FY 2025 fee-setting calculation, and more accurately project the associated establishment registration revenue, FDA decided to utilize the number of establishment registration fee-paying submission counts from FY 2023.

Table 3A—Three-Year Average of Fee-Paying Submissions

[Excluding establishment registration]

Application type	FY 2021 actual	FY 2022 actual	FY 2023 actual	3 Yr average
Full Fee applications	25	18	31	25
Small Business	5	3	3	4
Panel-Track Supplements	31	21	22	25
Small Business	6	1	5	4
De Novo Classifications	16	23	26	22
Small Business	42	53	68	54
180-Day Supplements	98	93	113	101
Small Business	34	31	12	26
Real-Time Supplements	150	140	138	143
Small Business	20	12	28	20
510(k)s	2,133	2,012	1,943	2,029
Small Business	1,846	1,757	2,031	1,878
30-Day Notice (Note also includes counts for 135 Day Supplements)	843	782	825	817
Small Business	77	67	53	66
513(g)(21 U.S.C. 360c(g)) Request for Classification Information	83	93	82	86
Small Business	53	58	59	57
Annual Fee for Periodic Reporting	613	620	657	630
Small Business	84	87	22	64

Table 3B—Fiscal Year 2023 Actual Fee-Paying Establishment Registration Submissions

Application type	FY 2023	FY 2025 estimate for registrations
Establishment Registrations	30,645	30,645

The information in tables 3A and 3B is necessary to estimate the amount of revenue that will be collected based on the fee amounts. Tables 4A and 4B display the FY 2025 base fees set in statute (column one) and the inflation adjusted base fees (per calculations in section III.A.) (column two). Using the inflation adjusted fees, the 3-year average of fee-paying submissions (excluding establishment registration), and the fee-paying establishment registration submissions from FY 2023, collections are projected to total $361,177,583 which is $32,532,417 lower than the inflation adjusted total revenue amount (in section II). Accordingly, the next step in the fee setting process is to increase the base fee amounts on a uniform proportionate basis to generate the inflation adjusted total revenue amounts (see 738(c)(2)(D)(ii) of the FD&C Act and table 4A, column three).

Applying these further adjusted fee rates to the 3-year average of fee-paying submissions, and the fee-paying establishment registration submissions from FY 2023 results in estimated total fee collections of $391,014,947 which is still $2,695,053 lower than the inflation adjusted total revenue amount (in Section II). The next step in the fee setting process, after the adjustment in (2)(D) is done, is to increase the base establishment registration fee amount as necessary for total fee collections to generate the inflation adjusted total revenue amount, as adjusted under paragraph (2) (see 738(c)(3) of the FD&C Act). Accordingly, the base establishment registration fee was increased by $88 for an establishment registration fee rate of $8,716 (see 738(c)(3) of the FD& C Act and table 4B, column three). The performance improvement adjustment amount is $17,282,544. Per statute, the establishment registration fee is further adjusted to account for the performance improvement adjustment amount. The inflation adjusted establishment registration fee is increased by $564 for an establishment registration fee of $9,280. The fees in column three in table 4A and column four in table 4B are those we are establishing for FY 2025, which are the standard fees.

Table 4A—Fees Needed To Achieve New FY 2025 Revenue Target

Application type	FY 2025 statutory fees (base fees)	FY 2025 inflation adjusted statutory base fees	Adjusted FY 2025 fees to meet revenue target (uniform proportionate increase)	3-Year average of fee-paying submissions	FY 2025 revenue from adjusted fees
Full Fee Applications	$445,000	$499,508	$540,783	25	$13,519,575
Small Business	111,250	124,877	135,196	4	540,784
Panel-Track Supplement	356,000	399,607	432,626	25	10,815,650
Small Business	89,000	99,902	108,157	4	432,628
De Novo Classification Request	133,500	149,583	162,235	22	3,569,170
Small Business	33,375	37,463	40,559	54	2,190,186
180-Day Supplements	66,750	74,926	81,117	101	8,192,817
Small Business	16,688	18,732	20,279	26	527,254
Real-Time Supplements	31,150	34,966	37,855	143	5,413,265
Small Business	7,788	8,741	9,464	20	189,280
510(k)s	20,025	22,478	24,335	2,029	49,375,715
Small Business	5,006	5,619	6,084	1,878	11,425,752
30-Day Notice	7,120	7,992	8,653	817	7,069,501
Small Business	3,560	3,996	4,326	66	285,516
513(g) Request for Classification Information	6,008	6,743	7,301	86	627,886
Small Business	3,004	3,372	3,650	57	208,050
Annual Fee for Periodic Reporting	15,575	17,483	18,927	630	11,924,010
Small Business	3,894	4,371	4,732	64	302,848
Total					126,609,887

Table 4B—Fees Needed To Achieve New FY 2025 Revenue Target Plus/Minus Adjustments

Application type	FY 2025 statutory fees (base fees)	FY 2025 inflation adjusted statutory base fees	Adjusted FY 2025 fees to meet inflation adjusted total revenue amount (uniform proportionate increase + further adjustment to establishment registrations)	Adjusted FY 2025 fees to meet inflation adjusted total revenue +/− adjustments	FY 2023 fee-paying submissions	FY 2025 revenue from adjusted fees
Establishment Registrations	$7,100	$7,970	$8,716	$9,280	30,645	$267,101,820

The standard fee (adjusted base amount) for a premarket application, including a BLA, and for a premarket report and a BLA efficacy supplement, is $540,783 for FY 2025. The fees set by reference to the standard fee for a premarket application are:

• For a panel-track supplement, 80 percent of the standard fee
• For a de novo classification request, 30 percent of the standard fee
• For a 180-day supplement, 15 percent of the standard fee
• For a real-time supplement, 7 percent of the standard fee
• For an annual fee for periodic reporting concerning a class III device, 3.5 percent of the standard fee
• For a 510(k) premarket notification, 4.5 percent of the standard fee
• For a 30-day notice, 1.6 percent of the standard fee
• For a 513(g) request for classification information, 1.35 percent of the standard fee

For all submissions other than a 30-day notice and a 513(g) request for classification information, the small business fee is 25 percent of the standard (full) fee for the submission (see section 738(d)(2)(C) and (e)(2)(C) of the FD&C Act). For a 30-day notice and a 513(g) request for classification information, the small business fee is 50 percent of the standard (full) fee for the submission (see section 738(d)(2)(C) of the FD&C Act).

The annual fee for establishment registration, after adjustments, is set at $9,280 for FY 2025. For FY 2025, there is no small business waiver for the annual establishment registration fee; all establishments pay the same fee.

For more information on reduced fees and waivers for small businesses, please see Section IX. Small Business Fee Reductions and Fee Waivers.

Table 5 summarizes the FY 2025 rates for all medical device fees.

Table 5—Medical Device Fees for FY 2025

Application fee type	Standard fee (as a percent of the standard fee for a premarket application)	FY 2025 standard fee	FY 2025 small business fee
Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262))	Base fee specified in statute	$540,783	$135,196
Premarket report (submitted under section 515(c)(2) of the FD&C Act)	100%	540,783	135,196
Efficacy supplement (to an approved BLA under section 351 of the PHS Act)	100%	540,783	135,196
Panel-track supplement	80%	432,626	108,157
De novo classification request	30%	162,235	40,559
180-day supplement	15%	81,117	20,279
Real-time supplement	7%	37,855	9,464
510(k) premarket notification submission	4.5%	24,335	6,084
30-day notice	1.60%	8,653	4,326
513(g) request for classification information	1.35%	7,301	3,650
Annual Fee Type
Annual fee for periodic reporting on a class III device	3.50%	18,927	4,732
Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(14))	Base fee specified in statute	9,280	9,280