Home/Federal/Federal Register/2023-15919

Notice2023-15919

Medical Device User Fee Rates for Fiscal Year 2024

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published

July 28, 2023

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) 2024. 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 2024, which apply from October 1, 2023, through September 30, 2024, and provides information on how the fees for FY 2024 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

Full Text

<html>
<head>
<title>Federal Register, Volume 88 Issue 144 (Friday, July 28, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48870-48878]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15919]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2965]

Medical Device User Fee Rates for Fiscal Year 2024

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2024. 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 2024, which apply from October 1, 2023, through September
30, 2024, and provides information on how the fees for FY 2024 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, 4041 Powder Mill
Rd., Beltsville, MD 20705-4304, 240-402-4989; or the User Fee Support
Staff at <a href="/cdn-cgi/l/email-protection#cf8080e280898d8e9fe2808982e29a89899ce288a0b9aabda1a2aaa1bb8fa9abaee1a7a7bce1a8a0b9">[email&#160;protected]</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

[[Page 48871]]

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 2024 is
$435,000. From this starting point, this document establishes FY 2024
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 21 U.S.C. 379j(d) and (e)). 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 2024 is $6,875. 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 2024

The total revenue amount for FY 2024 is $335,750,000, as set forth
in the statute prior to the inflation adjustment (see 21 U.S.C.
379j(b)(3)). 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 2024 are described in this document.

Inflation Adjustment

MDUFA specifies that the $335,750,000 is to be adjusted for
inflation increases for FY 2024 using two separate adjustments: one for
payroll costs and one for non-payroll costs (see 21 U.S.C. 379j(c)(2)).
The base inflation adjustment for FY 2024 is the sum of one plus the
two separate adjustments and is compounded as specified in the statute
(see 21 U.S.C. 379j(c)(2)(C) and 379j(c)(2)(B)).
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 position (FTE) at FDA
for the first 3 of the 4 preceding FYs, multiplied by 0.60, or 60
percent (see 21 U.S.C. 379j(c)(2)(C)).
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 2024. The 3-year average is 3.9280 percent
(rounded).

Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
FY 2020 FY 2021 FY 2022 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.............................. $2,875,592,000 $3,039,513,000 $3,165,477,000 ................
Total FTE............................... $17,535 $18,501 $18,474 ................
PC&B per FTE............................ $163,922 $164,289 $171,348 ................
Percent change from previous year....... 7.3063% 0.1811% 4.2967% 3.9280%
----------------------------------------------------------------------------------------------------------------

The payroll adjustment is 3.9280 percent multiplied by 60 percent,
or 2.3568 percent. The statute specifies that the component of the
inflation adjustment for non-payroll costs for FY 2024 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 21 U.S.C. 379j(c)(2)(C)).
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
----------------------------------------------------------------------------------------------------------------
2020 2021 2022 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.............................. 267.157 277.728 296.117 ................
Annual Percent Change................... 0.8989% 3.9568% 6.6212% ................
3-Year Average Percent Change in CPI.... ................ ................ ................ 3.8256%
----------------------------------------------------------------------------------------------------------------

The non-payroll adjustment is 3.8256 percent multiplied by 40
percent, or 1.5302 percent. Next, the payroll adjustment (2.3568
percent or 0.023568) is added to the non-payroll adjustment (1.5302
percent or .015302), for a total of 3.8870 percent (or 0.038870). To
complete the inflation adjustment, 1 (100 percent or 1.0) is added for
a total base inflation adjustment of 1.03887 for FY 2024.
MDUFA V provides for this inflation adjustment to be compounded for
FY 2023 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). To complete the compounded inflation adjustment for
FY 2024, the FY 2023 compounded adjustment (1.038870) is multiplied by
the FY 2024 base inflation adjustment (1.038935) to reach the
applicable inflation adjustment of 1.079318 (rounded) for FY 2024. We
then multiply the total revenue amount for FY 2024 ($335,750,000) by
1.079318, yielding an inflation adjusted total revenue amount of
$362,381,000 (rounded to the nearest thousand dollars).

[[Page 48872]]

III. Adjustments to Base Fee Amounts for FY 2024

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 21 U.S.C. 379j(a)(2)(A)).

A. Inflation Adjustment

MDUFA specifies that the base fees of $435,000 (premarket
application) and $6,875 (establishment registration) are to be adjusted
for FY 2024 using the same methodology as that for the total revenue
inflation adjustment in section II (see 21 U.S.C. 379j(c)(2)(D)(i)).
Multiplying the base fees by the compounded inflation adjustment of
1.079318 yields inflation adjusted base fees of $469,503 (premarket
application) and $7,420 (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 21
U.S.C. 379j(c)(2)(D)(ii)). After this adjustment, if necessary, FDA may
further increase the base establishment registration fees to generate
the inflation-adjusted total revenue amount (see 21 U.S.C. 379j(c)(3)).

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. Only the operating reserve adjustment
is potentially applicable in FY 2024.
1. Performance Improvement Adjustment
For FY 2024, there is no 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 21 U.S.C. 379j(c)(4)).
2. Hiring Adjustment
For FY 2024, there is no 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 21 U.S.C. 379j(c)(5)).
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 21 U.S.C. 379j(c)(6)). 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 21 U.S.C. 379j(c)(6)(C)). For FY 2024,
this excluded amount is $100,600,981.
The designated amount is equal to the sum of 13 weeks of operating
reserves of carryover user fees plus 1 month of operating reserves
described in 21 U.S.C. 379j(c)(8) (see 21 U.S.C. 379j(c)(6)(B)).
To determine the 13-week operating reserves of carryover user fees
amount, the FY 2024 inflation-adjusted total revenue amount,
$362,381,000 is divided by 52, and then multiplied by 13. The 13-week
operating reserve amount for FY 2024 is $90,595,250.
To determine the 1 month of operating reserves described in 21
U.S.C. 379j(c)(8), the FY 2024 inflation-adjusted total revenue amount
of $362,381,000 is divided by 12. The 1 month of operating reserves for
FY 2024 is $30,198,417.
For FY 2024, the designated amount is equal to the 13-week
operating reserve of $90,595,250 plus the 1 month of operating reserves
of $30,198,417, totaling $120,793,667.
To determine the FY 2023 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 2023) and added the
forecasted collections and obligations for the fourth quarter of FY
2023 to generate a full year estimate for FY 2023. The estimated end-
of-year FY 2023 operating reserves of carryover user fees is
$30,019,132. (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
($65,418,275). In addition, as noted above, for purposes of the
operating reserve adjustment, operating reserves of carryover user fees
do not include the estimated $100,600,981 remaining to spend at the end
of FY 2023 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 2023 MDUFA operating reserves
of carryover user fees amount totaling $30,019,132 does not exceed the
FY 2024 designated amount of $120,793,667 FDA will not decrease the
base establishment registration fee amounts for FY 2024 to provide for
not more than such designated amount.

IV. Calculation of Fee Rates

As noted in section II, the total revenue amount after the
applicable inflation adjustment is $362,381,000 (rounded to the nearest
thousand dollar). As noted in section III, there is no MDUFA V
adjustment solely to registration fees for FY 2024.
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 last 5 years and the 5-year average. 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 2024 fee-setting, this would be an
average of FY 2020 through FY 2022. 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 2024 fee-
setting calculation and more accurately project the associated
establishment registration revenue, FDA decided to average the number
of establishment registrations from FY 2018 through FY 2022. FDA
believes a 5-year average to estimate establishment registration volume
will

[[Page 48873]]

minimize the impact of the surge in fee paying establishment
registration volume in FY 2020 and FY 2021.

Table 3A--Three-Year Average of Fee-Paying Submissions (Excluding Establishment Registration)
----------------------------------------------------------------------------------------------------------------
Application type FY 2020 actual FY 2021 actual FY 2022 actual 3-Year average
----------------------------------------------------------------------------------------------------------------
Full Fee applications......................... 29 25 18 24
Small Business............................ 7 5 3 5
Panel-Track Supplements....................... 23 31 21 25
Small Business............................ 6 6 1 4
De Novo Classifications....................... 20 16 23 20
Small Business............................ 47 42 53 47
180-Day Supplements........................... 124 98 93 105
Small Business............................ 20 34 31 28
Real-Time Supplements......................... 175 150 140 155
Small Business............................ 28 20 12 20
510(k)s....................................... 2,048 2,133 2,012 2,064
Small Business............................ 1,667 1,846 1,757 1,757
30-Day Notice (Note also includes counts for 870 843 782 832
135 Day Supplements).........................
Small Business............................ 104 77 67 83
513(g)(21 U.S.C. 360c(g)) Request for 96 83 93 91
Classification Information...................
Small Business............................ 57 53 58 56
Annual Fee for Periodic Reporting............. 622 613 620 618
Small Business............................ 95 84 87 89
----------------------------------------------------------------------------------------------------------------

Table 3B--Five-Year Average of Fee-Paying Establishment Registration Submissions
----------------------------------------------------------------------------------------------------------------
Application type FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 5-Year average
----------------------------------------------------------------------------------------------------------------
Establishment Registrations. 27,544 27,728 41,942 33,812 31,748 32,555
----------------------------------------------------------------------------------------------------------------

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 B display the FY 2024 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 5-year average of fee-paying establishment
registration submissions, collections are projected to total
$351,531,781 which is $10,849,219 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 21 U.S.C. 379j(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 5-year average of fee-paying
establishment registration submissions results in estimated total fee
collections of $362,040,886, which is still $340,114 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 21 U.S.C.
379j(c)(3)). Accordingly, the base establishment registration fee was
increased by $11 for an establishment registration fee rate of $7,653
(see 21 U.S.C. 379j(c)(3)). The fees in column three in tables 4A and
4B are those we are establishing for FY 2024, which are the standard
fees.

Table 4A--Fees Needed To Achieve New FY 2024 Revenue Target
----------------------------------------------------------------------------------------------------------------
FY 2024
inflation Adjusted FY 2024
FY 2024 adjusted fees to meet 3-Year average FY 2024
Application type statutory fees statutory base revenue target of fee-paying revenue from
(base fees) fees (standard (standard fees) submissions adjusted fees
fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications....... $435,000 $469,503 $483,560 24 $11,605,440
Small Business.......... 108,750 117,376 120,890 5 604,450
Panel-Track Supplement...... 348,000 375,603 386,848 25 9,671,200
Small Business.......... 87,000 93,901 96,712 4 386,848
De Novo Classification 130,500 140,851 145,068 20 2,901,360
Request....................
Small Business.......... 32,625 35,213 36,267 47 1,704,549
180-Day Supplements......... 65,250 70,425 72,534 105 7,616,070
Small Business.......... 16,313 17,606 18,134 28 507,752
Real-Time Supplements....... 30,450 32,865 33,849 155 5,246,595
Small Business.......... 7,613 8,216 8,462 20 169,240
510(k)s..................... 19,575 21,128 21,760 2,064 44,912,640
Small Business.......... 4,894 5,282 5,440 1,757 9,558,080
30-Day Notice............... 6,960 7,512 7,737 832 6,437,184

[[Page 48874]]

Small Business.......... 3,480 3,756 3,869 83 321,127
513(g) Request for 5,873 6,338 6,528 91 594,048
Classification Information.
Small Business.......... 2,937 3,169 3,264 56 182,784
Annual Fee for Periodic 15,225 16,433 16,925 618 10,459,650
Reporting..................
Small Business.......... 3,806 4,108 4,231 89 376,559
-----------------------------------------------------------------------------------
Total............... .............. ................ ................ .............. 113,255,576
----------------------------------------------------------------------------------------------------------------

Table 4B--Fees Needed To Achieve New FY 2024 Revenue Target
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2024 inflation
FY 2024 adjusted Adjusted FY 2024 5-Year average FY 2024 revenue
Application type statutory fees statutory base fees to meet of fee-paying from adjusted
(base fees) fees (standard revenue target submissions fees
fees) (standard fees)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishment Registrations.................................... $6,875 $7,420 $7,653 32,555 $249,143,415
--------------------------------------------------------------------------------------------------------------------------------------------------------

The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $483,560 for FY 2024. 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; and
<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 21 U.S.C. 379j(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 21 U.S.C. 379j(d)(2)(C)).
The annual fee for establishment registration, after adjustments,
is set at $7,653 for FY 2024. For FY 2024, 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 2024 rates for all medical device fees.

Table 5--Medical Device Fees for FY 2024
----------------------------------------------------------------------------------------------------------------
Standard fee (as a percent of the
Application fee type standard fee for a premarket FY 2024 FY 2024 small
application) standard fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted Base fee specified in statute......... $483,560 $120,890
under section 515(c)(1) of the FD&C Act
(21 U.S.C. 360e(c)(1)), a PDP submitted
under section 515(f) of the FD&C Act,
or a BLA submitted under section 351 of
the Public Health Service Act (the PHS
Act) (42 U.S.C. 262)).
Premarket report (submitted under 100................................... 483,560 120,890
section 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA 100................................... 483,560 120,890
under section 351 of the PHS Act).
Panel-track supplement.................. 80.................................... 386,848 96,712
De novo classification request.......... 30.................................... 145,068 36,267
180-day supplement...................... 15.................................... 72,534 18,134
Real-time supplement.................... 7..................................... 33,849 8,462
510(k) premarket notification submission 4.5................................... 21,760 5,440
30-day notice........................... 1.60.................................. 7,737 3,869
513(g) request for classification 1.35.................................. 6,528 3,264
information.
Annual Fee Type......................... ...................................... .............. ..............
Annual fee for periodic reporting on a 3.50.................................. 16,925 4,231
class III device.
Annual establishment registration fee Base fee specified in statute......... 7,653 7,653
(to be paid by the establishment
engaged in the manufacture,
preparation, propagation, compounding,
or processing of a device, as defined
by 21 U.S.C. 379i(14)).
----------------------------------------------------------------------------------------------------------------

[[Page 48875]]

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. As a result, if the establishment
registration fee is the only medical device user fee that you will pay
in FY 2024, 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 2023, your
status as a small business will expire at the close of business on
September 30, 2023. You must re-qualify for FY 2024 in order to pay
small business fees during FY 2024.

A. Domestic (U.S.) Businesses

If you are a domestic (U.S.) business and wish to qualify as a
small business for FY 2024, 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: <a href="https://www.fda.gov/media/128050/download">https://www.fda.gov/media/128050/download</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 2023, except:
<bullet> If you submit your MDUFA Small Business Certification
Request for FY 2024 before April 15, 2024, and you have not yet filed
your return for 2023, you may use tax year 2022.
<bullet> If you submit your MDUFA Small Business Certification
Request for FY 2024 on or after April 15, 2024, and have not yet filed
your 2023 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 Industry and
Consumer Education at 800-638-2041 or 301-796-7100 or email at
<a href="/cdn-cgi/l/email-protection#b6f2fff5f3f6d0d2d798dedec598d1d9c0">[email&#160;protected]</a>.
4. Once you have completed your Form FDA 3602, print and sign the
form. Mail the completed form and your supporting documentation (copies
of the Federal (U.S.) income tax returns) to Medical Device User Fee
Small Business Certification Request mailing address, which is
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#094d404a4c496f6d682761617a276e667f">[email&#160;protected]</a>.

B. Foreign Businesses

If you are a foreign business, and wish to qualify as a small
business for FY 2024, 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: <a href="https://www.fda.gov/media/128059/download">https://www.fda.gov/media/128059/download</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#b6f2fff5f3f6d0d2d798dedec598d1d9c0">[email&#160;protected]</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 (2022 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#d3979a909693b5b7b2fdbbbba0fdb4bca5">[email&#160;protected]</a>.
4. Once you have completed your Form FDA 3602A, print and sign the
form. Mail the completed form and your supporting documentation,
including the following, to CDRH's Medical Device User Fee Small
Business Certification Request address, which is 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>.

[[Page 48876]]

<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 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
<a href="/cdn-cgi/l/email-protection#3f7b767c7a7f595b5e1157574c11585049">[email&#160;protected]</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, 2023, and September 30,
2024, you must pay the fee in effect for FY 2024. 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 2023 or FY 2024 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: <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, 2023. One choice is for
applications and fees that will be received on or before September 30,
2023, which are subject to FY 2023 fee rates. A second choice is for
applications and fees received on or after October 1, 2024, which are
subject to FY 2024 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 <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 U.S. bank accounts as well as U.S. credit
cards.
2. If paying with a paper check:
<bullet> 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.
<bullet> 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.
<bullet> 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. (Please note that this address is for payments of
application and annual report fees only and is not to be used for
payment of annual establishment registration fees.)
If you prefer to send a check by a courier, the courier may deliver
the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005
Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is
for courier delivery only. If you have any questions concerning courier
delivery contact U.S. Bank at 314-418-4013. This telephone number is
only for questions about courier delivery.)
3. 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.

[[Page 48877]]

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.
<bullet> Please write your invoice number on the check.
<bullet> Mail the paper check and a copy of the invoice to: Food
and Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
(Please note that this address is for payments of application and
annual report fees only and is not to be used for payment of annual
establishment registration fees.)
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, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery, contact U.S. Bank at 314-418-
4013. 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 <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 2024 until it has completed the steps below to
register and pay any applicable fee (see 21 U.S.C. 379j(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 2024 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 979108, St. Louis, MO 63197-9000. (Note: This address is
different from the address for payments of application and annual
report fees and is to be used only for payment of annual establishment
registration fees.)
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
979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S.
Bank address is for courier delivery only. If you have any questions
concerning courier delivery, contact U.S. Bank at 314-418-4013. 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 979108) 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 2024, or To Register a New Establishment for
FY 2024

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 tutorials that
demonstrate how to create a new FURLS user account if your
establishment did not create an account in FY 2023. 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

[[Page 48878]]

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#067463616a6f7572466562746e2860626728616970">[email&#160;protected]</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.gov/scripts/email/cber/bldregcontact.cfm">https://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm</a> 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
<a href="/cdn-cgi/l/email-protection#65212c2620250301044b0d0d164b020a13">[email&#160;protected]</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 (see 21 U.S.C.
379j(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

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 21 U.S.C.
379j(a)(2)(D).

Dated: July 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15919 Filed 7-27-23; 8:45 am]
BILLING CODE 4164-01-P

</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on July 28, 2023.

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.