[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
----------------------------------------------------------------------------------------------------------------
                                                 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

[[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
----------------------------------------------------------------------------------------------------------------
                                                  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

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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
----------------------------------------------------------------------------------------------------------------
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
------------------------------------------------------------------------
                                                    FY 2025 estimate for
        Application type              FY 2023          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
----------------------------------------------------------------------------------------------------------------
                                                               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)
----------------------------------------------------------------------------------------------------------------
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
                                   -----------------------------------------------------------------------------
        Total.....................  ............  ...........  ................  ..............      126,609,887
----------------------------------------------------------------------------------------------------------------


[[Page 61437]]


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