Notice2025-14412
Medical Device User Fee Rates for Fiscal Year 2026
Primary source
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Published
July 30, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2026. 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 2026, which apply from October 1, 2025, through September 30, 2026, and provides information on how the fees for FY 2026 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Full Text
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<title>Federal Register, Volume 90 Issue 144 (Wednesday, July 30, 2025)</title>
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[Federal Register Volume 90, Number 144 (Wednesday, July 30, 2025)]
[Notices]
[Pages 35895-35903]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14412]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2522]
Medical Device User Fee Rates for Fiscal Year 2026
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) 2026. 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 2026, which apply from October 1, 2025, through September
30, 2026, and provides information on how the fees for FY 2026 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: <a href="https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa">https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa</a>. For questions relating to the MDUFA
Small Business Program, please visit the Center for Devices and
Radiological Health's website: <a href="https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program">https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program</a>. 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 <a href="/cdn-cgi/l/email-protection#1346554040537577723d7b7b603d747c65"><span class="__cf_email__" data-cfemail="dd889b8e8e9dbbb9bcf3b5b5aef3bab2ab">[email protected]</span></a>.
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 2026 is
$455,000. From this starting point, this document establishes FY 2026
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 2026 is $7,575. Each establishment
that is registered (or is required to register) with the Secretary of
Health and Human Services under
[[Page 35896]]
section 510 of the FD&C Act, 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 2026
The total revenue amount for FY 2026 is $366,486,300, 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 2026 are described in this document.
Inflation Adjustment
MDUFA specifies that the $366,486,300 is to be adjusted for
inflation increases for FY 2026 using two separate adjustments: one for
payroll costs and one for non-payroll costs (see 738(c)(2)). The base
inflation adjustment for FY 2026 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 2026. The 3-year average is 5.4494 percent
(rounded).
Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
FY 2022 FY 2023 FY 2024 3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.............................. $3,165,477,000 $3,436,513,000 $3,791,729,000 ................
Total FTE............................... 18,474 18,729 19,687 ................
PC&B per FTE............................ $171,348 $183,486 $192,601 ................
Percent change from previous year....... 4.2967% 7.0838% 4.9677% 5.4494%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 5.4494 percent multiplied by 60 percent,
or 3.2696 percent. The statute specifies that the component of the
inflation adjustment for non-payroll costs for FY 2026 is the average
annual percent change that occurred in the Consumer Price Index (CPI)
for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not
Seasonally Adjusted; All Items; Annual Index) for the first 3 of the
preceding 4 years of available data multiplied by 0.40, or 40 percent
(see section 738(c)(2)(C)(i)(II) of the FD&C Act).
Table 2 provides the summary data and the 3-year average percent
change in the specified CPI for the Washington-Arlington-Alexandria
area. These data are published by the Bureau of Labor Statistics and
can be found on their website under series Id CUURS35ASA0 at: <a href="https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0">https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0</a>.
Table 2--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI
----------------------------------------------------------------------------------------------------------------
2022 2023 2024 3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.............................. 296.117 305.317 315.186 ................
Annual Percent Change................... 6.6212% 3.1069% 3.2324% ................
3-Year Average Percent Change in CPI.... ................ ................ ................ 4.3202%
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The non-payroll adjustment is 4.3202 percent multiplied by 40
percent, or 1.7281 percent. Next, the payroll adjustment (3.2696
percent or 0.032696) is added to the non-payroll adjustment (1.7281
percent or 0.017281), for a total of 4.9977 percent (or 0.049977). To
complete the inflation adjustment, 1 (100 percent or 1.0) is added for
a total base inflation adjustment of 1.049977 for FY 2026. 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 2026 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
2026, the FY 2025 compounded adjustment (1.122491) is multiplied by the
FY 2026 base inflation adjustment (1.040000) to reach the applicable
inflation adjustment of 1.167391 (rounded) for FY 2026. We then
multiply the total revenue amount for FY 2026 ($366,486,300) by
1.167391, yielding an inflation adjusted total revenue amount of
$427,833,000 (rounded to the nearest thousand dollars).
III. Adjustments to Base Fee Amounts for FY 2026
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)).
A. Inflation Adjustment
MDUFA specifies that the base fees of $455,000 (premarket
application) and $7,575 (establishment registration) are to be adjusted
for FY 2026 using the same methodology as that for the total revenue
inflation adjustment in section II (see section 738(c)(2)(D)(i) of the
FD&C Act). Multiplying the base fees by the compounded inflation
adjustment of 1.167391 yields inflation adjusted base fees of $531,163
(premarket application) and $8,843 (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
[[Page 35897]]
registration fees to generate the inflation-adjusted total revenue
amount (see section 738(c)(3)).
For FY 2026, further adjustments were required to meet the
inflation adjusted total revenue amount of $427,833,000. After
increasing base fees, on a uniform proportionate basis, and further
increasing establishment registration fees, this yields inflation
adjusted base fees of $579,272 (premarket application) and $9,760
(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
amount, which is set forth in the statute (see section 738(c)(4)). FDA
met the FY 2024 Pre-Submission Written Feedback goal and the FY 2023 De
Novo Decision goal, which determine the amount of the performance
improvement adjustment for FY 2026.
For FY 2026, the performance improvement adjustment amount is equal
to the product of (1) the sum of the pre-submission amount in section
738(c)(4)(B)(i)(II)(bb), $36,792,200 and the de novo classification
request amount in section 738(c)(4)(B)(ii)(I), $6,323,500 and (2) the
applicable inflation adjustment under section 738(c)(2)(B), 1.167391.
See section 738(c)(4)(A)(ii). For FY 2026, the performance improvement
adjustment is $50,332,880.
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)).
FDA met the FY 2024 statutory hiring threshold of 38 hires, so
establishment registration fees will not need to be lowered by the
hiring adjustment amount in FY 2026.
3. Operating Reserve Adjustment
For FYs 2023 to 2027, the operating reserve adjustment requires FDA
to decrease base establishment registration fees if the amount of
operating reserves of carryover user fees exceeds the ``designated
amount'', and such reduction is necessary to provide for not more than
such designated amount of operating reserves of carryover user fees
(see section 738(c)(6)(A)). 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)). For FY 2026,
this excluded amount is $61,892,215.
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)).
To determine the 13-week operating reserves of carryover user fees
amount, the FY 2026 inflation-adjusted total revenue amount (from
section II), $427,833,000, is added to the inflation-adjusted
performance improvement adjustment amount (from section III.C.1),
$50,332,880, resulting in $478,165,880. This amount is then divided by
52, and then multiplied by 13. The 13-week operating reserve amount for
FY 2026 is $119,541,470.
To determine the 1 month of operating reserves described in section
738(c)(8) of the FD&C Act, the FY 2026 inflation-adjusted total revenue
amount of $427,833,000 is added to the inflation-adjusted performance
improvement adjustment amount of $50,332,880, resulting in
$478,165,880. This amount is then divided by 12. The 1 month of
operating reserves for FY 2026 is $39,847,157.
For FY 2026, the designated amount is equal to the 13-week
operating reserve of $119,541,470 plus the 1 month of operating
reserves of $39,847,157, totaling $159,388,627.
To determine the FY 2025 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 2025) and added the
forecasted collections and obligations for the fourth quarter of FY
2025 to generate a full year estimate for FY 2025. The estimated end-
of-year FY 2025 operating reserves of carryover user fees is
$56,152,612 (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
($65,193,572). In addition, as noted above, for purposes of the
operating reserve adjustment, operating reserves of carryover user fees
do not include the estimated $61,892,215 remaining to spend at the end
of FY 2025 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 2025 MDUFA operating reserves
of carryover user fees amount totaling $56,152,612 does not exceed the
FY 2026 designated amount of $159,388,627 FDA will not decrease the
base establishment registration fee amounts for FY 2026 to provide for
not more than such designated amount.
As there is a performance improvement adjustment for FY 2026, but
no hiring adjustment or operating reserve adjustment, establishment
registration fees are increased to achieve an increase in total fee
collections for FY 2026 equal to the performance improvement adjustment
amount of $50,332,880. After so increasing establishment registration
fees only, this yields fees of $579,272 (premarket application) and
$11,423 (establishment registration).
IV. Calculation of Fee Rates
As noted in section II, the total revenue amount after the
applicable inflation adjustment is $427,833,000 (rounded to the nearest
thousand dollar). As noted in section III, the performance improvement
adjustment solely to registration fees for FY 2026 is $50,332,880.
There is no hiring adjustment or operating reserve adjustment for FY
2026.
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
2024). 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 2026 fee-setting, this
would be an average of FY
[[Page 35898]]
2022 through FY 2024. 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 2026 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 2024,
after making an adjustment to account for implementation of the small
business registration fee waiver for FY 2026.
Table 3A--Three-Year Average of Fee-Paying Submissions
[Excluding establishment registration]
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FY 2022 FY 2023 FY 2024
Application type Actual Actual Actual 3 Yr average
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Full Fee applications........................... 18 31 20 23
Small Business.............................. 3 3 4 3
Panel-Track Supplements......................... 21 22 26 23
Small Business.............................. 1 5 2 3
De Novo Classifications......................... 23 26 26 25
Small Business.............................. 53 68 47 56
180-Day Supplements............................. 93 113 127 111
Small Business.............................. 31 12 15 19
Real-Time Supplements........................... 140 138 157 145
Small Business.............................. 12 28 35 25
510(k)s......................................... 2,012 1,943 1,754 1,903
Small Business.............................. 1,757 2,031 2,066 1,951
30-Day Notice (Note also includes counts for 135 782 825 854 820
Day Supplements)...............................
Small Business.............................. 67 53 62 61
513(g)(21 U.S.C. 360c(g)) Request for 93 82 65 80
Classification Information.....................
Small Business.............................. 58 59 68 62
Annual Fee for Periodic Reporting............... 620 657 700 659
Small Business.............................. 87 22 32 47
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Table 3B--Fiscal Year 2024 Actual Fee-Paying
[Establishment registration submissions]
------------------------------------------------------------------------
FY 2026
Application type FY 2024 Estimate for
registrations
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Establishment Registrations........... 30,280 30,270
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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 2026 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 2024, collections are projected to total
$389,083,279 which is $38,749,721 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) 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 2024 results in estimated total fee collections of
$424,326,053 which is still $3,506,947 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)). Accordingly,
the base establishment registration fee was increased by $116 for an
establishment registration fee rate of $9,760 (see 738(c)(3) and table
4B, column three). The performance improvement adjustment amount is
$50,332,880. 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
$1,663 for an establishment registration fee of $11,423. The fees in
column three in table 4A and column four in table 4B are those we are
establishing for FY 2026, which are the standard fees.
[[Page 35899]]
Table 4A--Fees Needed To Achieve New FY 2026 Revenue Target
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Adjusted FY
FY 2026 2026 fees to
FY 2026 Inflation meet revenue 3-Year FY 2026 Revenue
Application type Statutory adjusted target average of from adjusted
fees (base statutory (uniform fee-paying fees
fees) base fees proportionate submissions
increase)
----------------------------------------------------------------------------------------------------------------
Full Fee Application......... $455,000 $531,163 $579,272 23 $13,323,256
Small Business........... 113,750 132,791 144,818 3 434,454
Panel-Track Supplement....... 364,000 424,930 463,418 23 10,658,614
Small Business........... 91,000 106,233 115,855 3 347,565
De Novo Classification 136,500 159,349 173,782 25 4,344,550
Request.....................
Small Business........... 34,125 39,837 43,446 56 2,432,976
180-Day Supplement........... 68,250 79,674 86,891 111 9,644,901
Small Business........... 17,063 19,919 21,723 19 412,737
Real-Time Supplement......... 31,850 37,181 40,549 145 5,879,605
Small Business........... 7,963 9,295 10,137 25 253,425
510(k) Premarket Notification 20,475 23,902 26,067 1,903 49,605,501
Submission..................
Small Business........... 5,119 5,976 6,517 1,951 12,714,667
30-Day Notice................ 7,280 8,499 9,268 820 7,599,760
Small Business........... 3,640 4,249 4,634 61 282,674
513(g) Request for 6,143 7,171 7,820 80 625,600
Classification Information..
Small Business........... 3,072 3,585 3,910 62 242,420
Annual Fee for Periodic 15,925 18,591 20,275 659 13,361,225
Reporting...................
Small Business........... 3,981 4,648 5,069 47 238,243
----------------------------------------------------------------------------------
Total................ .............. .............. .............. .............. 132,402,173
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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 $579,272 for FY 2026.
The fees set by reference to the standard fee for a premarket
application are:
<bullet> For a panel-track supplement, 80 percent of the standard fee
<bullet> For a de novo classification request, 30 percent of the
standard fee
<bullet> For a 180-day supplement, 15 percent of the standard fee
<bullet> For a real-time supplement, 7 percent of the standard fee
<bullet> For an annual fee for periodic reporting concerning a class
III device, 3.5 percent of the standard fee
<bullet> For a 510(k) premarket notification, 4.5 percent of the
standard fee
<bullet> For a 30-day notice, 1.6 percent of the standard fee
<bullet> 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 738(d)(2)(C) and
(e)(2)(C)). 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 738(d)(2)(C)).
Table 4B--Fees Needed To Achieve New FY 2026 Revenue Target Plus/Minus Adjustments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adjusted FY 2026
fees to meet
inflation adjusted Adjusted FY
FY 2026 total revenue amount 2026 fees to
FY 2026 inflation (Uniform meet inflation FY 2024 fee- FY 2026
Application type statutory fees adjusted Proportionate adjusted total paying revenue from
(base fees) statutory base Increase + Further revenue +/- submissions adjusted fees
fees Adjustment to adjustments
Establishment
Registrations)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishment Registrations.................. $7,575 $8,843 $9,760 $11,423 30,270 $295,435,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
The annual fee for establishment registration, after adjustments,
is set at $11,423 for FY 2026. For FY 2026, FDA may, but is not
required to, grant a waiver of the fee for annual establishment
registration (excluding the initial registration) to applicants that
qualify as a small business if FDA finds that the establishment is a
small business and paying the fee for such a year represents a
financial hardship to the establishment as determined by FDA. 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 2026 rates for all medical device fees.
[[Page 35900]]
Table 5--Medical Device Fees for FY 2026
----------------------------------------------------------------------------------------------------------------
Standard fee (as a percent of
Application fee type the standard fee for a premarket FY 2026 FY 2026 small
application) (%) standard fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under Base fee specified in statute... $579,272 $144,818
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............................. 579,272 144,818
515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under 100............................. 579,272 144,818
section 351 of the PHS Act).
Panel-track supplement........................ 80.............................. 463,418 115,855
De novo classification request................ 30.............................. 173,782 43,446
180-day supplement............................ 15.............................. 86,891 21,723
Real-time supplement.......................... 7............................... 40,549 10,137
510(k) premarket notification submission...... 4.5............................. 26,067 6,517
30-day notice................................. 1.60............................ 9,268 4,634
513(g) request for classification information. 1.35............................ 7,820 3,910
Annual Fee Type:
Annual fee for periodic reporting on a 3.50............................ 20,275 5,069
class III device.
Annual establishment registration fee (to Base fee specified in statute... 11,423 11,423
be paid by the establishment engaged in
the manufacture, preparation,
propagation, compounding, or processing
of a device, as defined by 21 U.S.C.
379i(14)).
----------------------------------------------------------------------------------------------------------------
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.
For FY 2026, FDA may, but is not required to, grant a waiver of the
annual establishment registration fee (excluding the initial
registration) to applicants that qualify as a small business if FDA
finds that the establishment is a small business and paying the fee for
such a year represents a financial hardship to the establishment as
determined by FDA. For the purpose of the annual registration fee
waiver, a small business is defined as one with $1,000,000 or less in
gross receipts or sales in the most recent Federal (U.S.) income tax
return (including the returns of its affiliates). For more information
on obtaining such a waiver, see FDA's draft Select Updates for the
Medical Device User Fee Small Business Qualification and Certification
Guidance, which, when final, will describe FDA's current thinking on
the topic.
If your business qualified as a small business for FY 2025, your
status as a small business will expire at the close of business on
September 30, 2025. You must re-qualify for FY 2026 in order to pay
small business fees during FY 2026.
A. Domestic (U.S.) Businesses
If you are a domestic (U.S.) business and wish to qualify as a
small business for FY 2026, submit the following to FDA:
1. A completed MDUFA Small Business Request for a Business
Headquartered in the United States. The most current FDA Form may be
found in the FDA Forms database: <a href="https://www.fda.gov/about-fda/reports-manuals-forms/forms">https://www.fda.gov/about-fda/reports-manuals-forms/forms</a>.
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 2025, except:
<bullet> If you submit your MDUFA Small Business Request for FY
2026 before April 15, 2026, and you have not yet filed your return for
2025, you may use tax year 2024.
<bullet> If you submit your MDUFA Small Business Request for FY
2026 on or after April 15, 2026, and have not yet filed your 2025
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:
<bullet> 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
<bullet> 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.
<bullet> If your affiliate is headquartered in a country without a
National Taxing Authority, please contact the Division of
[[Page 35901]]
Industry and Consumer Education at 800-638-2041 or 301-796-7100 or
email at <a href="/cdn-cgi/l/email-protection#66222f252326000207480e0e1548010910"><span class="__cf_email__" data-cfemail="43070a0006032527226d2b2b306d242c35">[email protected]</span></a>.
4. Once you have completed and signed the most current FDA Form for
a MDUFA Small Business Request, 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: <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm">https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm</a>.
If you need assistance, please contact the Division of Industry and
Consumer Education at 800-638-2041 or 301-796-7100 or email at
<a href="/cdn-cgi/l/email-protection#16525f555356707277387e7e6538717960"><span class="__cf_email__" data-cfemail="2c68656f696c4a484d0244445f024b435a">[email protected]</span></a>.
B. Foreign Businesses
If you are a foreign business, and wish to qualify as a small
business for FY 2026, submit the following:
1. A completed MDUFA Foreign Small Business Request for a Business
Headquartered Outside the United States. The most current FDA Form is
provided in the FDA Forms database: <a href="https://www.fda.gov/about-fda/reports-manuals-forms/forms">https://www.fda.gov/about-fda/reports-manuals-forms/forms</a>.
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 <a href="/cdn-cgi/l/email-protection#c6828f858386a0a2a7e8aeaeb5e8a1a9b0"><span class="__cf_email__" data-cfemail="fdb9b4beb8bd9b999cd395958ed39a928b">[email protected]</span></a>.
3. For each of your affiliates, either:
<bullet> 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 (2024 or later), or
<bullet> 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.
<bullet> 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
<a href="/cdn-cgi/l/email-protection#cd89848e888daba9ace3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="7b3f32383e3b1d1f1a55131308551c140d">[email protected]</span></a>.
4. Once you have completed and signed the most current MDUFA Small
Business request, submit your form and your supporting documentation,
including the following, using the instructions which are available at
the following website: <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm">https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm</a>.
<bullet> A copy of the most recent Federal (U.S.) income tax return
for each of your affiliates headquartered in the U.S. and
<bullet> A National Taxing Authority Certification 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
<a href="/cdn-cgi/l/email-protection#82c6cbc1c7c2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="a1e5e8e2e4e1c7c5c08fc9c9d28fc6ced7">[email protected]</span></a>.
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, 2025, and September 30,
2026, you must pay the fee in effect for FY 2026. 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 2025 or FY 2026 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.
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: <a href="https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp">https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp</a>. Complete the Medical Device User Fee cover sheet.
Be sure you choose the correct application submission date range. (Two
choices will be offered until October 1, 2025. One choice is for
applications and fees that will be received on or before September 30,
2025, which are subject to FY 2025 fee rates. A second choice is for
applications and fees received on or after October 1, 2025, which are
subject to FY 2026 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).\1\ FDA has partnered
with the U.S. Department of the Treasury to utilize <a href="http://Pay.gov">Pay.gov</a>, 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 <a href="https://userfees.fda.gov/pay">https://userfees.fda.gov/pay</a>. (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
<a href="http://Pay.gov">Pay.gov</a>. 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
[[Page 35902]]
U.S bank accounts as well as U.S. credit cards.
---------------------------------------------------------------------------
\1\ See ``Change in Federal Payment and Collection Options''
announcement published in the Federal Register on June 27, 2025 (90
FR 27639).
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2. If paying with a wire transfer:
<bullet> 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.
<bullet> 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 <a href="https://www.fda.gov/cdrhsubmissionaddress">https://www.fda.gov/cdrhsubmissionaddress</a>.
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 <a href="https://userfees.fda.gov/pay">https://userfees.fda.gov/pay</a> (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 <a href="http://Pay.gov">Pay.gov</a>. 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. 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 <a href="https://userfees.fda.gov/OA_HTML/furls.jsp">https://userfees.fda.gov/OA_HTML/furls.jsp</a>. (FDA has verified the website
address, but FDA is not responsible for any subsequent changes to the
website 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 2026 until it has completed the steps below to
register and pay any applicable fee (see 738(f)(2)).
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 2026 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.
If you have an approved small business waiver, please reach out to
the User Fee Support Staff at <a href="/cdn-cgi/l/email-protection#d98c9f8a8a99bfbdb8f7b1b1aaf7beb6af"><span class="__cf_email__" data-cfemail="4316051010032527226d2b2b306d242c35">[email protected]</span></a> for further
instructions.
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 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 2026, or To Register a New Establishment for
FY 2026
Go to the Center for Devices and Radiological Health's website at
<a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing">https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing</a> 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
[[Page 35903]]
tutorials that demonstrate how to create a new FURLS user account if
your establishment did not create an account in FY 2025. Manufacturers
of licensed biologics should register in the electronic Blood
Establishment Registration (eBER) system at <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-establishment-registration">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-establishment-registration</a>.
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:
<a href="/cdn-cgi/l/email-protection#c6b4a3a1aaafb5b286a5a2b4aee8a0a2a7e8a1a9b0"><span class="__cf_email__" data-cfemail="611304060d08121521020513094f0705004f060e17">[email protected]</span></a> 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 <a href="https://www.accessdata.fda">https://www.accessdata.fda</a> .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
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
<a href="/cdn-cgi/l/email-protection#81c5c8c2c4c1e7e5e0afe9e9f2afe6eef7"><span class="__cf_email__" data-cfemail="fcb8b5bfb9bc9a989dd294948fd29b938a">[email protected]</span></a>.
A. Premarket Approval Fee Reduction or Waiver
A small business applicant may request to pay a reduced rate for
premarket approval fees. An applicant may also request a fee waiver for
their first premarket application or premarket report (738(d)).
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 2026, FDA may, but is not required to, grant a waiver of the
annual establishment registration fee (excluding the initial
registration) to applicants that qualify as a small business if FDA
finds that the establishment is a small business and paying the fee for
such a year represents a financial hardship to the establishment as
determined by FDA.
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. For more information on qualifying and submitting a refund,
see section 738(a)(2)(D) of the FD&C Act (21 U.S.C. 379j(a)(2)(D)).
Dated: July 25, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14412 Filed 7-29-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on July 30, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.