[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Notices]
[Pages 61433-61441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16883]
[[Page 61433]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3453]
Medical Device User Fee Rates for Fiscal Year 2025
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Medical Device User Fee Amendments of 2022 (MDUFA V),
authorizes FDA to collect user fees for certain medical device
submissions and annual fees both for certain periodic reports and for
establishments subject to registration. This notice establishes the fee
rates for FY 2025, which apply from October 1, 2024, through September
30, 2025, and provides information on how the fees for FY 2025 were
determined, the payment procedures you should follow, and how you may
qualify for reduced small business fees.
FOR FURTHER INFORMATION CONTACT:
For information on Medical Device User Fees: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa.
For questions relating to the MDUFA Small Business Program, please
visit the Center for Devices and Radiological Health's website: https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program.
For questions relating to this notice: Olufunmilayo Ariyo, Office
of Financial Management, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903, 240-402-4989; or the User Fee
Support Staff at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The FD&C Act, as amended by MDUFA V, authorizes FDA to collect user
fees for certain medical device submissions and annual fees both for
certain periodic reports and for establishments subject to
registration. Section 738 of the FD&C Act (21 U.S.C. 379j) establishes
fees for certain medical device applications, submissions, supplements,
notices, and requests (for simplicity, this document refers to these
collectively as ``submissions'' or ``applications''); for periodic
reporting on class III devices; and for the registration of certain
establishments.
Under the FD&C Act, the fee rate for each type of submission is set
at a specified percentage of the standard fee for a premarket
application (a premarket application is a premarket approval
application (PMA), a product development protocol (PDP), or a biologics
license application (BLA)). The FD&C Act specifies the base fee for a
premarket application for each year from FY 2023 through FY 2027; the
base fee for a premarket application received by FDA during FY 2025 is
$445,000. From this starting point, this document establishes FY 2025
fee rates for certain types of submissions, and for periodic reporting,
by applying criteria specified in the FD&C Act. Under statutorily
defined conditions, a qualified applicant may receive a fee waiver or
may pay a lower small business fee (see sections 738(a)(3)(B), 738(d)
and 738(e) of the FD&C Act). For more information on fee waivers,
please see Section IX. Small Business Fee Reductions and Fee Waivers.
The FD&C Act specifies the base fee for establishment registration
for each year from FY 2023 through FY 2027; the base fee for an
establishment registration in FY 2025 is $7,100. Each establishment
that is registered (or is required to register) with the Secretary of
Health and Human Services under section 510 of the FD&C Act (21 U.S.C.
360), because such establishment is engaged in the manufacture,
preparation, propagation, compounding, or processing of a device, is
required to pay the annual fee for establishment registration.
II. Total Revenue Amount for FY 2025
The total revenue amount for FY 2025 is $350,746,400, as set forth
in the statute prior to the inflation adjustment (see section 738(b)(3)
of the FD&C Act). MDUFA V directs FDA to use the yearly total revenue
amount as a starting point to set the standard fee rates for each fee
type. The fee calculations for FY 2025 are described in this document.
Inflation Adjustment
MDUFA specifies that the $350,746,400 is to be adjusted for
inflation increases for FY 2025 using two separate adjustments: one for
payroll costs and one for non-payroll costs (see section 738(c)(2) of
the FD&C Act). The base inflation adjustment for FY 2025 is the sum of
one plus the two separate adjustments and is compounded as specified in
the statute (see section 738(c)(2)(C) and 738(c)(2)(B) of the FD&C
Act).
The component of the inflation adjustment for payroll costs is the
average annual percent change in the cost of all personnel compensation
and benefits (PC&B) paid per full-time equivalent (FTE) position at FDA
for the first 3 of the 4 preceding FYs, multiplied by 0.60, or 60
percent (see section 738(c)(2)(C)(i)(I) of the FD&C Act).
Table 1 summarizes the actual cost and FTE data for the specified
FYs, provides the percent change from the previous fiscal year, and
provides the average percent change over the first 3 of the 4 fiscal
years preceding FY 2025. The 3-year average is 3.8539 percent
(rounded).
Table 1--FDA PC&Bs Each Year and Percent Change
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FY 2021 FY 2022 FY 2023 3-Year average
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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%
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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
[[Page 61434]]
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
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2021 2022 2023 3-Year average
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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%
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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
[[Page 61435]]
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]
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Application type FY 2021 actual FY 2022 actual FY 2023 actual 3 Yr average
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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 135 843 782 825 817
Day Supplements)...............................
Small Business.............................. 77 67 53 66
513(g)(21 U.S.C. 360c(g)) Request for 83 93 82 86
Classification Information.....................
Small Business.............................. 53 58 59 57
[[Page 61436]]
Annual Fee for Periodic Reporting............... 613 620 657 630
Small Business.............................. 84 87 22 64
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Table 3B--Fiscal Year 2023 Actual Fee-Paying Establishment Registration
Submissions
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FY 2025 estimate for
Application type FY 2023 registrations
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Establishment Registrations..... 30,645 30,645
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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
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Adjusted FY 2025
FY 2025 FY 2025 fees to meet
statutory inflation revenue target 3-Year average FY 2025 revenue
Application type fees (base adjusted (uniform of fee-paying from adjusted
fees) statutory proportionate submissions fees
base fees increase)
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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 6,008 6,743 7,301 86 627,886
Information......................
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
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Total..................... ............ ........... ................ .............. 126,609,887
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[[Page 61437]]
Table 4B--Fees Needed To Achieve New FY 2025 Revenue Target Plus/Minus Adjustments
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Adjusted FY 2025 fees to
meet inflation adjusted Adjusted FY
FY 2025 total revenue amount 2025 fees to
FY 2025 inflation (uniform proportionate meet inflation FY 2023 fee- FY 2025 revenue
Application type statutory fees adjusted increase + further adjusted total paying from adjusted
(base fees) statutory adjustment to revenue +/- submissions fees
base fees establishment adjustments
registrations)
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Establishment Registrations................. $7,100 $7,970 $8,716 $9,280 30,645 $267,101,820
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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
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Standard fee (as a percent of
Application fee type the standard fee for a premarket FY 2025 FY 2025 small
application) standard fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under Base fee specified in statute... $540,783 $135,196
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)).
Premarket report (submitted under section 100%............................ 540,783 135,196
515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under 100%............................ 540,783 135,196
section 351 of the PHS Act).
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 3.50%........................... 18,927 4,732
III device.
Annual establishment registration fee (to be Base fee specified in statute... 9,280 9,280
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)).
----------------------------------------------------------------------------------------------------------------
V. How To Qualify as a Small Business for Purposes of Medical Device
Fees
If your business, including your affiliates, has gross receipts or
sales of no more than $100 million for the most recent tax year, you
may qualify for reduced small business fees. If your business,
including your affiliates, has gross sales or receipts of no more than
$30 million, you may also qualify for a waiver of the fee for your
first premarket application (i.e., PMA, PDP, or BLA) or premarket
report. If you want to pay the small business fee rate for a submission
or you want to receive a waiver of the fee for your first premarket
application or premarket report, you must submit the materials showing
you qualify as a small business at least 60 days before you send your
submission to FDA. For more information on fee waivers or reductions,
please see Section IX. Small Business Fee Reductions and Fee Waivers.
Please note that the establishment registration fee is not eligible
for a reduced small business fee. For FY 2025, there is no small
business waiver for the annual establishment registration fee. As a
result, if the establishment registration fee is the only medical
device user fee that you will pay in FY 2025, you should not submit a
Small Business Certification Request. FDA will review your information
and determine whether you qualify as a small business eligible for the
reduced fee and/or fee waiver. If you make a submission before FDA
finds that you qualify as a small business, you must pay the standard
(full) fee for that submission.
If your business qualified as a small business for FY 2024, your
status as a small business will expire at the close of business on
September 30, 2024. You must re-qualify for FY 2025 in order to pay
small business fees during FY 2025.
[[Page 61438]]
A. Domestic (U.S.) Businesses
If you are a domestic (U.S.) business and wish to qualify as a
small business for FY 2025, submit the following to FDA:
1. A completed MDUFA Small Business Certification Request for a
Business Headquartered in the United States (Form FDA 3602). Form FDA
3602 is provided in the FDA Forms database: https://www.fda.gov/about-fda/reports-manuals-forms/forms.
2. A signed copy of your Federal (U.S.) Income Tax Return for the
most recent tax year. The most recent tax year will be 2024, except:
If you submit your MDUFA Small Business Certification
Request for FY 2025 before April 15, 2025, and you have not yet filed
your return for 2024, you may use tax year 2023.
If you submit your MDUFA Small Business Certification
Request for FY 2025 on or after April 15, 2025, and have not yet filed
your 2024 return because you obtained an extension, you may submit your
most recent return filed prior to the extension.
3. For each of your affiliates, either:
If the affiliate is a domestic (U.S.) business, a signed
copy of the affiliate's Federal (U.S.) Income Tax Return for the most
recent tax year, or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority, if extant, of the country in which the firm
is headquartered. The National Taxing Authority is the foreign
equivalent of the U.S. Internal Revenue Service. This certification
must show the amount of gross receipts or sales for the most recent tax
year, in both U.S. dollars and the local currency of the country, the
exchange rate used in converting the local currency to U.S. dollars,
and the dates of the gross receipts or sales collected. The business
must also submit a statement signed by the head of the business's firm
or by its chief financial officer that the business has submitted
certifications for all of its affiliates, identifying the name of each
affiliate, or that the business has no affiliates.
If your affiliate is headquartered in a country without a
National Taxing Authority, please contact the Division of Industry and
Consumer Education at 800-638-2041 or 301-796-7100 or email at
[email protected].
4. Once you have completed and signed your Form FDA 3602, submit
your form and your supporting documentation (copies of the Federal
(U.S.) income tax returns), using the instructions which are available
at the following website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm.
If you need assistance, please contact the Division of Industry and
Consumer Education at 800-638-2041 or 301-796-7100 or email at
[email protected].
B. Foreign Businesses
If you are a foreign business, and wish to qualify as a small
business for FY 2025, submit the following:
1. A completed MDUFA Foreign Small Business Certification Request
for a Business Headquartered Outside the United States (Form FDA
3602A). Form FDA 3602A is provided in the FDA Forms database: https://www.fda.gov/about-fda/reports-manuals-forms/forms.
2. A National Taxing Authority Certification, completed by, and
bearing the official seal of, the National Taxing Authority, if extant,
of the country in which the firm is headquartered. This certification
must show the amount of gross receipts or sales for the most recent tax
year, in both U.S. dollars and the local currency of the country, the
exchange rate used in converting the local currency to U.S. dollars,
and the dates of the gross receipts or sales collected.
If your firm is headquartered in a country without a National
Taxing Authority, please contact the Division of Industry and Consumer
Education at 800-638-2041 or 301-796-7100 or email at [email protected].
3. For each of your affiliates, either:
If the affiliate is a domestic (U.S.) business, a signed
copy of the affiliate's Federal (U.S.) Income Tax Return for the most
recent tax year (2023 or later), or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority, if extant, of the country in which the firm
is headquartered. The National Taxing Authority is the foreign
equivalent of the U.S. Internal Revenue Service. This certification
must show the amount of gross receipts or sales for the most recent tax
year, in both U.S. dollars and the local currency of the country, the
exchange rate used in converting the local currency to U.S. dollars,
and the dates for the gross receipts or sales collected. The business
must also submit a statement signed by the head of the business's firm
or by its chief financial officer that the applicant has submitted
certifications for all of its affiliates, identifying the name of each
affiliate, or that the business has no affiliates.
If your affiliate is headquartered in a country without a
National Taxing Authority, please contact the Division of Industry and
Consumer Education at 800-638-2041 or 301-796-7100 or email at
[email protected].
4. Once you have completed and signed your Form FDA 3602A, submit
your form and your supporting documentation, including the following,
using the instructions which are available at the following website:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm.
A copy of the most recent Federal (U.S.) income tax return
for each of your affiliates headquartered in the U.S. and
A copy of an MDUFA Foreign Small Business Certification
Request for each of your foreign affiliates.
If you need assistance, please contact the Division of Industry and
Consumer Education at 800-638-2041 or 301-796-7100 or email at
[email protected].
VI. Procedures for Paying Application Fees
If your application or submission is subject to a fee and your
payment is received by FDA between October 1, 2024, and September 30,
2025, you must pay the fee in effect for FY 2025. To avoid delay in the
review of your application, you should pay the application fee at the
time you submit your application to FDA. The later of the date that the
application is received in the reviewing center's document room or the
date the U.S. Treasury recognizes the payment determines whether the
fee rates for FY 2024 or FY 2025 apply. FDA must receive the correct
fee at the time that an application is submitted, or the application
will not be accepted for filing or review.
FDA requests that you follow the steps below before submitting a
medical device application subject to a fee to ensure that FDA links
the fee with the correct application. (Note: Do not send your user fee
check to FDA with the application.)
A. Secure a Payment Identification Number (PIN) and Medical Device User
Fee Cover Sheet From FDA Before Submitting Either the Application or
the Payment
Log into the User Fee System at: https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp. Complete the Medical Device User Fee cover sheet.
Be sure you choose the correct application
[[Page 61439]]
submission date range. (Two choices will be offered until October 1,
2024. One choice is for applications and fees that will be received on
or before September 30, 2024, which are subject to FY 2024 fee rates. A
second choice is for applications and fees received on or after October
1, 2024, which are subject to FY 2025 fee rates.) After completing data
entry, print a copy of the Medical Device User Fee cover sheet and note
the unique PIN located in the upper right-hand corner of the printed
cover sheet.
B. Electronically Transmit a Copy of the Printed Cover Sheet With the
PIN
When you are satisfied that the data on the cover sheet is
accurate, electronically transmit that data to FDA according to
instructions on the screen. Applicants are required to set up a user
account and password to assure data security in the creation and
electronic submission of cover sheets.
C. Submit Payment for the Completed Medical Device User Fee Cover Sheet
1. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American Express). FDA has partnered with
the U.S. Department of the Treasury to utilize Pay.gov, a web-based
payment system, for online electronic payment. You may make a payment
via electronic check or credit card after submitting your cover sheet.
Secure electronic payments can be submitted using the User Fees Payment
Portal at https://userfees.fda.gov/pay. Note: Only full payments are
accepted. No partial payments can be made online. Once you search for
your invoice, select ``Pay Now'' to be redirected to Pay.gov.
Electronic payment options are based on the balance due. Payment by
credit card is available for balances that are less than $25,000. If
the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S bank accounts as well as U.S. credit
cards.
2. If paying with a paper check:
All paper checks must be in U.S. currency from a U.S. bank
and made payable to the Food and Drug Administration. If needed, FDA's
tax identification number is 53-0196965.
Please write your application's unique PIN (from the upper
right-hand corner of your completed Medical Device User Fee cover
sheet) on your check.
Mail the paper check and a copy of the completed cover
sheet to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO
63197-9000.
If you prefer to send a check by a courier, the courier may deliver
the check to: U.S. Bank, Attn: Government Lockbox 979033, 3180 Rider
Trail S, Earth City, MO 63045. (Note: This U.S. Bank address is for
courier delivery only. If you have any questions concerning courier
delivery contact U.S. Bank at 800-495-4981. This telephone number is
only for questions about courier delivery).
3. If paying with a wire transfer:
Please include your application's unique PIN (from the
upper right-hand corner of your completed Medical Device User Fee cover
sheet) in your wire transfer. Without the PIN, your payment may not be
applied to your cover sheet and review of your application may be
delayed.
The originating financial institution may charge a wire
transfer fee. If the financial institution charges a wire transfer fee
it is required that you add that amount to the payment to ensure that
the invoice is paid in full.
Use the following account information when sending a wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.
FDA records the official application receipt date as the later of
the following: (1) the date the application was received by the FDA
Document Control Center for the reviewing Center or (2) the date the
U.S. Treasury recognizes the payment.
D. Submit Your Application to FDA With a Copy of the Completed Medical
Device User Fee Cover Sheet
Please submit your application and a copy of the completed Medical
Device User Fee cover sheet to the address located at https://www.fda.gov/cdrhsubmissionaddress.
VII. Procedures for Paying the Annual Fee for Periodic Reporting
You will be invoiced at the end of the quarter in which your PMA
Periodic Report is due. Invoices will be sent based on the details
included on your PMA file. You are responsible for ensuring FDA has
your current billing information, and you may update your contact
information for the PMA by submitting an amendment to the pending PMA
or a supplement to the approved PMA.
1. The preferred payment method is online using electronic check
(ACH also known as eCheck) or credit card (Discover, VISA, MasterCard,
American Express). Secure electronic payments can be submitted using
the User Fees Payment Portal at https://userfees.fda.gov/pay (Note:
Only full payments are accepted. No partial payments can be made
online). Once you search for your invoice, select ``Pay Now'' to be
redirected to Pay.gov. Note that electronic payment options are based
on the balance due. Payment by credit card is available for balances
that are less than $25,000. If the balance exceeds this amount, only
the ACH option is available. Payments must be made using U.S. bank
accounts as well as U.S. credit cards.
2. If paying with a paper check: The check must be in U.S. currency
from a U.S. bank and made payable to the Food and Drug Administration.
If needed, FDA's tax identification number is 53-0196965.
Please write your invoice number on the check.
Mail the paper check and a copy of the invoice to: Food
and Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
To send a check by a courier, the courier must deliver the check
and printed copy of the cover sheet to U.S. Bank, Attn: Government
Lockbox 979033, 3180 Rider Trail S, Earth City, MO 63045. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery, contact U.S. Bank at 800-495-
4981. This telephone number is only for questions about courier
delivery).
3. When paying by a wire transfer, it is required that the invoice
number is included; without the invoice number the payment may not be
applied. If the payment amount is not applied, the invoice amount would
be referred to collections. The originating financial institution may
charge a wire transfer fee. If the financial institution charges a wire
transfer fee, it is required that you add that amount to the payment to
ensure that the invoice is paid in full.
Use the following account information when sending a wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.
VIII. Procedures for Paying Annual Establishment Registration Fees
To pay the annual establishment registration fee, firms must access
the Device Facility User Fee (DFUF) website at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the website
address, but FDA is not responsible for any subsequent changes to the
website
[[Page 61440]]
address after this document publishes in the Federal Register.) Create
a DFUF order and you will be issued a PIN when you place your order.
After payment has been processed, you will be issued a payment
confirmation number (PCN). You will not be able to register your
establishment if you do not have a PIN and a PCN. An establishment
required to pay an annual establishment registration fee is not legally
registered in FY 2025 until it has completed the steps below to
register and pay any applicable fee (see section 738(f)(2) of the FD&C
Act).
Companies that do not manufacture any product other than a licensed
biologic are required to register in the Blood Establishment
Registration (BER) system. FDA's Center for Biologics Evaluation and
Research (CBER) will send establishment registration fee invoices
annually to these companies.
A. Submit a DFUF Order With a PIN From FDA Before Registering or
Submitting Payment
To submit a DFUF Order, you must create or have previously created
a user account and password for the user fee website listed previously
in this section. After creating a username and password, log into the
Establishment Registration User Fee FY 2025 store. Complete the DFUF
order by entering the number of establishments you are registering that
require payment. When you are satisfied that the information in the
order is accurate, electronically transmit that data to FDA according
to instructions on the screen. Print a copy of the final DFUF order and
note the unique PIN located in the upper right-hand corner of the
printed order.
B. Pay for Your DFUF Order
Unless paying by U.S. credit card, all payments must be in U.S.
currency and drawn on a U.S. bank.
1. If paying by credit card or electronic check (ACH or eCheck):
The DFUF order will include payment information, including details on
how you can pay online using a credit card or electronic check. Follow
the instructions provided to make an electronic payment.
2. If paying with a paper check: The check must be in U.S. currency
and drawn on a U.S. bank, and mailed to: Food and Drug Administration,
P.O. Box 979033, St. Louis, MO 63197-9000.
If a check is sent by a courier that requests a street address, the
courier can deliver the check to: U.S. Bank, Attn: Government Lockbox
979033, 3180 Rider Trail S, Earth City, MO 63045. (Note: This U.S. Bank
address is for courier delivery only. If you have any questions
concerning courier delivery, contact U.S. Bank at 800-495-4981. This
telephone number is only for questions about courier delivery.)
Please make sure that both of the following are written on your
check: (1) the FDA post office box number (P.O. Box 979033) and (2) the
PIN that is printed on your order. Include a copy of your printed order
when you mail your check.
3. If paying with a wire transfer: Wire transfers may also be used
to pay annual establishment registration fees. To send a wire transfer,
please read and comply with the following information:
Include your order's unique PIN (in the upper right-hand corner of
your completed DFUF order) in your wire transfer. Without the PIN, your
payment may not be applied to your facility and your registration may
be delayed.
The originating financial institution may charge a wire transfer
fee. If the financial institution charges a wire transfer fee, it is
required that you add that amount to the payment to ensure that the
invoice is paid in full. Use the following account information when
sending a wire transfer: U.S. Dept. of the Treasury, TREAS NYC, 33
Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No.
021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number
is 53-0196965.
C. Complete the Information Online To Update Your Establishment's
Annual Registration for FY 2025, or To Register a New Establishment for
FY 2025
Go to the Center for Devices and Radiological Health's website at
https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing and click the ``Access Electronic
Registration'' link on the left side of the page. This opens a new page
with important information about the FDA Unified Registration and
Listing System (FURLS). After reading this information, click on the
``Access Electronic Registration'' link in the middle of the page. This
link takes you to an FDA Industry Systems page with tutorials that
demonstrate how to create a new FURLS user account if your
establishment did not create an account in FY 2024. Manufacturers of
licensed biologics should register in the electronic Blood
Establishment Registration (eBER) system at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-establishment-registration.
Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu, click on the Device Registration
and Listing Module (DRLM) of FURLS button. New establishments will need
to register, and existing establishments will update their annual
registration using choices on the DRLM menu. When you choose to
register or update your annual registration, the system will prompt you
through the entry of information about your establishment and your
devices. If you have any problems with this process, email:
[email protected] or call 301-796-7400 for assistance. (Note: This
email address and this telephone number are for assistance with
establishment registration only; they are not to be used for questions
related to other aspects of medical device user fees.) Problems with
the eBER system should be directed to https://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm or call 240-402-8360.
D. Enter Your DFUF Order PIN and PCN
After completing your annual or initial registration and device
listing, you will be prompted to enter your DFUF order PIN and PCN,
when applicable. This process does not apply to establishments engaged
only in the manufacture, preparation, propagation, compounding, or
processing of licensed biologic devices. CBER will send invoices for
payment of the establishment registration fee to such establishments.
IX. Small Business Fee Reductions and Fee Waivers
To qualify for reduced fees for small businesses or a small
business fee waiver, please see the requirements for qualification
provided in Section V. How To Qualify as a Small Business for Purposes
of Medical Device Fees. The applicant should submit a Small Business
Certification Request and the supporting materials showing you qualify
as a small business at least 60 days before you send your submission to
FDA. FDA will review your information and determine whether you qualify
as a small business eligible for the reduced fee and/or fee waiver. If
you make a submission before FDA finds that you qualify as a small
business, you must pay the standard (full) fee for that submission.
If you need assistance, please contact the Division of Industry and
Consumer Education at 800-638-2041 or 301-796-7100 or email at
[email protected].
A. Premarket Approval Fee Reduction or Waiver
A small business applicant may request to pay a reduced rate for
[[Page 61441]]
premarket approval fees. An applicant may also request a fee waiver for
their first premarket application or premarket report (section 738(d)
of the FD&C Act).
B. Premarket Notification Submission Fee Reduction
A small business applicant may request to pay a reduced rate for a
premarket notification submission.
C. Annual Establishment Registration Fee Waiver
For FY 2025, there is no small business waiver for the annual
establishment registration fee; all establishments pay the same fee.
X. Refunds
To qualify for consideration for a refund, a person shall submit to
FDA a written request for a refund not later than 180 days after such
fee is due. FDA has discretion to refund a fee or a portion of the fee.
A determination by FDA concerning a refund shall not be reviewable. For
more information on qualifying and submitting a refund, see section
738(a)(2)(D) of the FD&C Act.
Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16883 Filed 7-30-24; 8:45 am]
BILLING CODE 4164-01-P