83 FR 36598 - Medical Device User Fee Rates for Fiscal Year 2019

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 146 (July 30, 2018)

Page Range		36598-36604
FR Document		2018-16178

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), 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 2019, which apply from October 1, 2018, through September 30, 2019. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. 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 2019, you should not submit a Small Business Certification Request. This document provides information on how the fees for FY 2019 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

Federal Register, Volume 83 Issue 146 (Monday, July 30, 2018)

[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Pages 36598-36604]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-16178]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]

Medical Device User Fee Rates for Fiscal Year 2019

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) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV),
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 2019, which apply from October 1, 2018, through September
30, 2019. To avoid delay in the review of your application, you should
pay the application fee before or at the time you submit your
application to FDA. The fee you must pay is the fee that is in effect
on the later of the date that your application is received by FDA or
the date your fee payment is recognized by the U.S. Treasury. If you
want to pay a reduced small business fee, you must qualify as a small
business before making your submission to FDA; if you do not qualify as
a small business before making your submission to FDA, you will have to
pay the higher standard fee. 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 2019, you should not submit a
Small Business Certification Request. This document provides
information on how the fees for FY 2019 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: Visit FDA's website
at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm20081521.htm.
For questions relating to the MDUFA Small Business Program, please
visit CDRH's website: https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/ucm577696.htm.
For questions relating to this notice: David Haas, Office of
Financial Management, Food and Drug Administration, 8455 Colesville Rd.
(COLE-14202I), Silver Spring, MD 20993-0002, 240-402-9845.

SUPPLEMENTARY INFORMATION:

I. Background

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 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)).
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 2018 through FY 2022; the
base fee for a premarket application received by FDA during FY 2019 is
$300,000. From this starting point, this document establishes FY 2019
fee rates for certain types of submissions, and for periodic reporting,
by applying criteria specified in the FD&C Act.
The FD&C Act specifies the base fee for establishment registration
for each year from FY 2018 through FY 2022; the base fee for an
establishment registration in FY 2019 is $4,548. There is no reduction
in the registration fee for small businesses. 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. Revenue Amount for FY 2019

The total revenue amount for FY 2019 is $190,654,875, as set forth
in the statute prior to the inflation adjustment (see 21 U.S.C.
379j(b)(3)). MDUFA 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 2019 are described in this document.

Inflation Adjustment

MDUFA specifies that the $190,654,875 is to be adjusted for
inflation increases for FY 2019 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 2019 is the sum of one plus these
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, and provides the percent change from the previous FY and the
average percent change over the first 3 of the 4 FYs preceding FY 2019.
The 3-year average is 2.4152 percent (rounded).

Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2015 2016 2017 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.................................. $2,232,304,000 $2,414,728,159 $2,581,551,000 ...............

[[Page 36599]]

Total FTE................................... 15,484 16,381 17,022 ...............
PC&B per FTE................................ $144,168 $147,408 $151,660 ...............
Percent change from previous year........... 2.1136 2.2474 2.8845 2.4152
----------------------------------------------------------------------------------------------------------------

The payroll adjustment is 2.4152 percent multiplied by 60 percent,
or 1.4491 percent.
The statute specifies that the component of the inflation
adjustment for non-payroll costs for FY 2019 is the average annual
percent change that occurred in the Consumer Price Index (CPI) for
urban consumers (Washington-Baltimore, DC-MD-VA-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 Baltimore-Washington area. These
data are published by the Bureau of Labor Statistics and can be found
on their website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURA311SA0,CUUSA311SA0.

Table 2--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI
----------------------------------------------------------------------------------------------------------------
Fiscal year 2015 2016 2017 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.................................. 155.353 157.180 159.202 ...............
Annual Percent Change....................... 0.3268 1.1760 1.2864 ...............
3-Year Average Percent Change in CPI........ ............... ............... ............... 0.9297
----------------------------------------------------------------------------------------------------------------

The non-pay adjustment is 0.9297 percent multiplied by 40 percent,
or 0.3719 percent.
Next, the payroll adjustment (1.4491 percent or 0.014491) is added
to the non-payroll adjustment (0.3719 percent or 0.003719), for a total
of 1.8210 percent (or 0.018210). To complete the inflation adjustment,
1 (100 percent or 1.0) is added for a total base inflation adjustment
of 1.018210 for FY 2019.
MDUFA IV provides for this inflation adjustment to be compounded
for FY 2019 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). The base inflation adjustment for FY 2019
(1.018210) is compounded by multiplying it by the compounded applicable
inflation factor from FY 2018 (1.054618). To complete the compounded
inflation adjustment for FY 2019, the FY 2018 compounded adjustment
(1.054618) is multiplied by the FY 2019 base inflation adjustment
(1.018210) to reach the applicable inflation adjustment of 1.073823
(rounded) for FY 2019. We then multiply the total revenue amount for FY
2019 ($190,654,875) by 1.073823, yielding an inflation adjusted total
revenue amount of $204,730,000 (rounded to the nearest thousand
dollars).

III. Fees for FY 2019

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 $300,000 (premarket
application) and $4,548 (establishment registration) are to be adjusted
for FY 2019 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
1.073823 yields inflation adjusted base fees of $322,147 (premarket
application) and $4,884 (establishment registration).

B. Further Adjustments

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)). If necessary after this adjustment, 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. Calculation of Fee Rates

Table 3 provides the last 3 years of fee-paying submission counts
and the 3-year average. These numbers are used to project the fee-
paying submission counts that FDA will receive in FY 2019. Most of the
fee-paying submission counts are published in the MDUFA Financial
Report to Congress each year.

Table 3--Three-Year Average of Fee-Paying Submissions
----------------------------------------------------------------------------------------------------------------
Application type FY 2015 actual FY 2016 actual FY 2017 actual 3-Year average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications........... 42 37 40 40
Small Business.............. 7 10 7 8
Panel-Track Supplement.......... 22 17 27 22
Small Business.............. 3 1 2 2
De Novo Classification Request .................. .................. 24 24
\1\............................
Small Business \1\.......... .................. .................. 31 31
180-Day Supplements............. 143 116 184 148
Small Business.............. 15 16 36 22
Real-Time Supplements........... 204 179 195 193
Small Business.............. 28 27 20 25
510(k)s......................... 2,768 2,599 3,141 2,836
Small Business.............. 1,037 1,005 1,125 1,056

[[Page 36600]]

30-Day Notice................... 920 929 1,080 976
Small Business.............. 71 76 82 76
513(g) (21 U.S.C. 360c(g)) 75 68 98 80
Request for Classification
Information....................
Small Business.............. 33 46 41 40
Annual Fee for Periodic 554 582 429 522
Reporting \2\..................
Small Business \2\.......... 73 75 37 62
Establishment Registration...... 25,363 26,046 27,268 26,226
----------------------------------------------------------------------------------------------------------------
\1\ Three-year average for De Novo is based on estimate for FY 2019.
\2\ Includes collection of quarter 4 billing for FY 2017 during FY 2018.

The information in table 3 is necessary to estimate the amount of
revenue that will be collected based on the fee amounts. Table 4
displays the FY 2019 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 and the 3-year averages
of fee paying submissions, collections are projected to total
$207,708,611, which is $2,978,611 higher than the inflation adjusted
total revenue amount. The fees in column two are those we are
establishing in FY 2019, which are the standard fees.

Table 4--Fees Needed to Achieve New FY 2019 Revenue Target
----------------------------------------------------------------------------------------------------------------
FY 2019 inflation
FY 2019 statutory adjusted statutory FY 2019 revenue
Application type fees (base fees) base fees from adjusted fees
(standard fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications............................... $300,000 $322,147 $12,885,880
Small Business.................................. 75,000 80,537 644,296
Panel-Track Supplement.............................. 225,000 241,610 5,315,420
Small Business.................................. 56,250 60,403 120,806
De Novo Classification Request...................... 90,000 96,644 2,319,456
Small Business.................................. 22,500 24,161 748,991
180-Day Supplements................................. 45,000 48,322 7,151,656
Small Business.................................. 11,250 12,081 265,782
Real-Time Supplements............................... 21,000 22,550 4,352,150
Small Business.................................. 5,250 5,638 140,950
510(k)s............................................. 10,200 10,953 31,062,708
Small Business.................................. 2,550 2,738 2,891,328
30-Day Notice....................................... 4,800 5,154 5,030,304
Small Business.................................. 2,400 2,577 195,852
513(g) Request for Classification Information....... 4,050 4,349 347,920
Small Business.................................. 2,025 2,175 87,000
Annual Fee for Periodic Reporting................... 10,500 11,275 5,885,550
Small Business.................................. 2,625 2,819 174,778
Establishment Registration.......................... 4,548 4,884 128,087,784
-----------------------------------------------------------
Total........................................... .................. .................. 207,708,611
----------------------------------------------------------------------------------------------------------------

The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $322,147 for FY 2019. The fees set by reference
to the standard fee for a premarket application are:
For a panel-track supplement, 75 percent of the standard
fee;
For a de novo classification request, 30 percent of the
standard fee;
For a 180-day supplement, 15 percent of the standard fee;
For a real-time supplement, 7 percent of the standard fee;
For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the standard fee;
For a 510(k) premarket notification, 3.4 percent of the
standard fee;
For a 30-day notice, 1.6 percent of the standard fee; and
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 adjustment, is
set at $4,884 for FY 2019. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
Table 5 summarizes the FY 2019 rates for all medical device fees.

[[Page 36601]]

Table 5--Medical Device Fees for FY 2019
----------------------------------------------------------------------------------------------------------------
Standard fee (as a percent of the
Application fee type standard fee for a premarket FY 2019 standard FY 2019 small
application) fee business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA Base fee specified in statute.... $322,147 $80,537
submitted under section 515(c)(1) of
the FD&C Act (21 U.S.C. 360e(c)(1)),
a PDP submitted under section 515(f)
of the FD&C Act (21 U.S.C. 360e(f),
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.............................. 322,147 80,537
section 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved 100.............................. 322,147 80,537
BLA under section 351 of the PHS
Act).
Panel-track supplement............... 75............................... 241,610 60,403
De novo classification request....... 30............................... 96,644 24,161
180-day supplement................... 15............................... 48,322 12,081
Real-time supplement................. 7................................ 22,550 5,638
510(k) premarket notification 3.40............................. 10,953 2,738
submission.
30-day notice........................ 1.60............................. 5,154 2,577
513(g) request for classification 1.35............................. 4,349 2,175
information.
Annual Fee Type...................... ................................. .................. ..................
Annual fee for periodic reporting on 3.50............................. 11,275 2,819
a class III device.
Annual establishment registration fee Base fee specified in statute.... 4,884 4,884
(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(13)).
----------------------------------------------------------------------------------------------------------------

IV. 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 should submit the 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 your business qualified as a small business for FY 2018, your
status as a small business will expire at the close of business on
September 30, 2018. You must re-qualify for FY 2019 in order to pay
small business fees during FY 2019.
If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2019, you must submit the following to FDA:
1. A completed MDUFA Small Business Certification Request For a
Business Headquartered in the U.S. (Form FDA 3602). Form FDA 3602 is
provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573420.pdf.
2. A signed certified copy of your Federal (U.S.) Income Tax Return
for the most recent tax year. The most recent tax year will be 2018,
except:
If you submit your MDUFA Small Business Certification Request for
FY 2019 before April 15, 2019, and you have not yet filed your return
for 2018, you may use tax year 2017.
If you submit your MDUFA Small Business Certification Request for
FY 2019 on or after April 15, 2019, and have not yet filed your 2018
return because you obtained an extension, you may submit your most
recent return filed prior to the extension.
3. For each of your affiliates, either:
If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year, or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates of
the gross receipts or sales collected. The business must also submit a
statement signed by the head of the business's firm or by its chief
financial officer that the business has submitted certifications for
all of its affiliates, identifying the name of each affiliate, or that
the business has no affiliates.
If you are a foreign business, and wish to qualify as a small
business for FY 2019, you must submit the following:
1. A completed MDUFA Foreign Small Business Certification Request
For a Business Headquartered Outside the United States (Form FDA
3602A). Form FDA 3602A is provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573423.pdf.
2. A National Taxing Authority Certification, completed by, and
bearing the official seal of, the National Taxing Authority 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.
3. For each of your affiliates, either:
If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year (2018 or later), or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the

[[Page 36602]]

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.

V. 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, 2018, and September 30,
2019, you must pay the fee in effect for FY 2019. 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 2018 or FY 2019 apply. FDA must receive
the correct fee at the time that an application is submitted, or the
application will not be accepted for filing or review.
FDA requests that you follow the steps below before submitting a
medical device application subject to a fee to ensure that FDA links
the fee with the correct application. (Note: Do not send your user fee
check to FDA with the application.)

A. Secure a Payment Identification Number (PIN) and Medical Device User
Fee Cover Sheet From FDA Before Submitting Either the Application or
the Payment

Log into the User Fee System at: https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp. Complete the Medical Device User Fee cover sheet.
Be sure you choose the correct application submission date range. (Two
choices will be offered until October 1, 2018. One choice is for
applications and fees that will be received on or before September 30,
2018, which are subject to FY 2018 fee rates. A second choice is for
applications and fees received on or after October 1, 2018, which are
subject to FY 2019 fee rates.) After completing data entry, print a
copy of the Medical Device User Fee cover sheet and note the unique PIN
located in the upper right-hand corner of the printed cover sheet.

B. Electronically Transmit a Copy of the Printed Cover Sheet With the
PIN

When you are satisfied that the data on the cover sheet is
accurate, electronically transmit that data to FDA according to
instructions on the screen. Applicants are required to set up a user
account and password to assure data security in the creation and
electronic submission of cover sheets.

C. Submit Payment for the Completed Medical Device User Fee Cover Sheet

1. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American Express). FDA has partnered with
the U.S. Department of the Treasury to utilize Pay.gov, a web-based
payment system, for online electronic payment. You may make a payment
via electronic check or credit card after submitting your cover sheet.
Secure electronic payments can be submitted using the User Fees Payment
Portal at https://userfees.fda.gov/pay. Note: Only full payments are
accepted. No partial payments can be made online. Once you search for
your invoice, select ``Pay Now'' to be redirected to Pay.gov.
Electronic payment options are based on the balance due. Payment by
credit card is available for balances that are less than $25,000. If
the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S bank accounts as well as U.S. credit
cards.
2. If paying with a paper check:
All paper checks must be in U.S. currency from a U.S. bank
and made payable to the Food and Drug Administration. If needed, FDA's
tax identification number is 53-0196965.
Please write your application's unique PIN (from the upper
right-hand corner of your completed Medical Device User Fee cover
sheet) on your check.
Mail the paper check and a copy of the completed cover
sheet to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO
63197-9000. (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:
Please include your application's unique PIN (from the
upper right-hand corner of your completed Medical Device User Fee cover
sheet) in your wire transfer. Without the PIN, your payment may not be
applied to your cover sheet and review of your application may be
delayed.
The originating financial institution may charge a wire
transfer fee. If the financial institution charges a wire transfer fee
it is required that you add that amount to the payment to ensure that
the invoice is paid in full.
Use the following account information when sending a wire transfer:
U.S. Department of 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. It is helpful if the fee arrives
at the bank at least 1 day before the application arrives at FDA.

D. Submit Your Application to FDA With a Copy of the Completed Medical
Device User Fee Cover Sheet

Please submit your application and a copy of the completed Medical
Device User Fee cover sheet to the address located at https://www.fda.gov/cdrhsubmissionaddress.

VI. Procedures for Paying the Annual Fee for Periodic Reporting

You will be invoiced at the end of the quarter in which your PMA
Periodic Report is due. Invoices will be sent based on the details
included on your PMA file. You are responsible for ensuring FDA has
your current billing information, and you may update your contact
information for the PMA by submitting an amendment to the pending PMA
or a supplement to the approved PMA.
1. The preferred payment method is online using electronic check
(ACH also known as eCheck) or credit card (Discover, VISA, MasterCard,
American Express). Secure electronic payments can be submitted using
the User Fees Payment Portal at https://userfees.fda.gov/pay (Note:
Only full payments are accepted. No partial payments can be made
online). Once you search for your invoice, select ``Pay Now'' to be
redirected to Pay.gov. Note that electronic payment options are based
on the balance due. Payment by

[[Page 36603]]

credit card is available for balances that are less than $25,000. If
the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S. bank accounts as well as U.S. credit
cards.
2. If paying with a paper check:
The check must be in U.S. currency from a U.S. bank and made
payable to the Food and Drug Administration. If needed, FDA's tax
identification number is 53-0196965.
Please write your invoice number on the check.
Mail the paper check and a copy of the invoice to: Food
and Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
(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.

VII. Procedures for Paying Annual Establishment Registration Fees

To pay the annual establishment registration fee, firms must access
the Device Facility User Fee (DFUF) website at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the website
address, but FDA is not responsible for any subsequent changes to the
website 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 2019 until it has completed the steps below to
register and pay any applicable fee (see 21 U.S.C. 379j(g)(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 user name and password, log into the
Establishment Registration User Fee FY 2019 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 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 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 2019, or To Register a New Establishment for
FY 2019

Go to the Center for Devices and Radiological Health's website at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm and click the
``Access Electronic Registration'' link on the left side of the page.
This opens up 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 2018.
Manufacturers of licensed biologics should register in the BER system
at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm.
Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu,

[[Page 36604]]

click on the Device Registration and Listing Module (DRLM) of FURLS
button. New establishments will need to register and existing
establishments will update their annual registration using choices on
the DRLM menu. When you choose to register or update your annual
registration, the system will prompt you through the entry of
information about your establishment and your devices. If you have any
problems with this process, email: [email protected] or call 301-
796-7400 for assistance. (Note: This email address and this telephone
number are for assistance with establishment registration only; they
are not to be used for questions related to other aspects of medical
device user fees.) Problems with the BER system should be directed to
https://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm or
call 240-402-8360.

D. Enter Your DFUF Order PIN and PCN

After completing your annual or initial registration and device
listing, you will be prompted to enter your DFUF order PIN and PCN,
when applicable. This process does not apply to establishments engaged
only in the manufacture, preparation, propagation, compounding, or
processing of licensed biologic devices. CBER will send invoices for
payment of the establishment registration fee to such establishments.

Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16178 Filed 7-27-18; 8:45 am]
BILLING CODE 4164-01-P

36598 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices

FoodborneIllnessRiskFactorReduction/ making your submission to FDA, you by FDA during FY 2019 is $300,000.
ucm224321.htm. will have to pay the higher standard fee. From this starting point, this document
4. FDA National Retail Food Team. ‘‘FDA Please note that the establishment establishes FY 2019 fee rates for certain
Trend Analysis Report on the registration fee is not eligible for a types of submissions, and for periodic
Occurrence of Foodborne Illness Risk
Factors in Selected Institutional
reduced small business fee. As a result, reporting, by applying criteria specified
Foodservice, Restaurant, and Retail Food if the establishment registration fee is in the FD&C Act.
Store Facility Types (1998–2008).’’ the only medical device user fee that The FD&C Act specifies the base fee
Available at: https://wayback.archive- you will pay in FY 2019, you should not for establishment registration for each
it.org/7993/20170406022950/https:// submit a Small Business Certification year from FY 2018 through FY 2022; the
www.fda.gov/Food/GuidanceRegulation/ Request. This document provides base fee for an establishment
RetailFoodProtection/FoodborneIllness information on how the fees for FY 2019 registration in FY 2019 is $4,548. There
RiskFactorReduction/ucm223293.htm. were determined, the payment is no reduction in the registration fee for
5. ‘‘FDA Food Code.’’ Available at: https:// procedures you should follow, and how
www.fda.gov/FoodCode.
small businesses. Each establishment
you may qualify for reduced small that is registered (or is required to
Dated: July 24, 2018. business fees. register) with the Secretary of Health
Leslie Kux, FOR FURTHER INFORMATION CONTACT: and Human Services under section 510
Associate Commissioner for Policy. For information on Medical Device of the FD&C Act (21 U.S.C. 360) because
[FR Doc. 2018–16189 Filed 7–27–18; 8:45 am]
User Fees: Visit FDA’s website at: such establishment is engaged in the
https://www.fda.gov/ForIndustry/ manufacture, preparation, propagation,
BILLING CODE 4164–01–P
UserFees/MedicalDeviceUserFee/ compounding, or processing of a device
ucm20081521.htm. is required to pay the annual fee for
DEPARTMENT OF HEALTH AND For questions relating to the MDUFA establishment registration.
HUMAN SERVICES Small Business Program, please visit
II. Revenue Amount for FY 2019
CDRH’s website: https://www.fda.gov/
Food and Drug Administration medicaldevices/deviceregulation The total revenue amount for FY 2019
andguidance/howtomarketyourdevice/ is $190,654,875, as set forth in the
[Docket No. FDA–2017–N–0007] premarketsubmissions/ucm577696.htm. statute prior to the inflation adjustment
For questions relating to this notice: (see 21 U.S.C. 379j(b)(3)). MDUFA
Medical Device User Fee Rates for
David Haas, Office of Financial directs FDA to use the yearly total
Fiscal Year 2019
Management, Food and Drug revenue amount as a starting point to set
AGENCY: Food and Drug Administration, Administration, 8455 Colesville Rd. the standard fee rates for each fee type.
HHS. (COLE–14202I), Silver Spring, MD The fee calculations for FY 2019 are
ACTION: Notice. 20993–0002, 240–402–9845. described in this document.
SUPPLEMENTARY INFORMATION: Inflation Adjustment
SUMMARY: The Food and Drug
Administration (FDA) is announcing the I. Background MDUFA specifies that the
fee rates and payment procedures for Section 738 of the FD&C Act (21 $190,654,875 is to be adjusted for
medical device user fees for fiscal year U.S.C. 379j) establishes fees for certain inflation increases for FY 2019 using
(FY) 2019. The Federal Food, Drug, and medical device applications, two separate adjustments—one for
Cosmetic Act (FD&C Act), as amended submissions, supplements, notices, and payroll costs and one for non-payroll
by the Medical Device User Fee requests (for simplicity, this document costs (see 21 U.S.C. 379j(c)(2)). The base
Amendments of 2017 (MDUFA IV), refers to these collectively as inflation adjustment for FY 2019 is the
authorizes FDA to collect user fees for ‘‘submissions’’ or ‘‘applications’’); for sum of one plus these two separate
certain medical device submissions and periodic reporting on class III devices; adjustments, and is compounded as
annual fees both for certain periodic and for the registration of certain specified in the statute (see 21 U.S.C.
reports and for establishments subject to establishments. Under statutorily 379j(c)(2)(C) and 379j(c)(2)(B)).
registration. This notice establishes the defined conditions, a qualified The component of the inflation
fee rates for FY 2019, which apply from applicant may receive a fee waiver or adjustment for payroll costs is the
October 1, 2018, through September 30, may pay a lower small business fee (see average annual percent change in the
2019. To avoid delay in the review of 21 U.S.C. 379j(d) and (e)). cost of all personnel compensation and
your application, you should pay the Under the FD&C Act, the fee rate for benefits (PC&B) paid per full-time
application fee before or at the time you each type of submission is set at a equivalent position (FTE) at FDA for the
submit your application to FDA. The fee specified percentage of the standard fee first 3 of the 4 preceding FYs,
you must pay is the fee that is in effect for a premarket application (a premarket multiplied by 0.60, or 60 percent (see 21
on the later of the date that your application is a premarket approval U.S.C. 379j(c)(2)(C)).
application is received by FDA or the application (PMA), a product Table 1 summarizes the actual cost
date your fee payment is recognized by development protocol (PDP), or a and FTE data for the specified FYs, and
the U.S. Treasury. If you want to pay a biologics license application (BLA)). provides the percent change from the
reduced small business fee, you must The FD&C Act specifies the base fee for previous FY and the average percent
qualify as a small business before a premarket application for each year change over the first 3 of the 4 FYs
making your submission to FDA; if you from FY 2018 through FY 2022; the base preceding FY 2019. The 3-year average
daltland on DSKBBV9HB2PROD with NOTICES

do not qualify as a small business before fee for a premarket application received is 2.4152 percent (rounded).

TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
Fiscal year 2015 2016 2017 3-Year average

Total PC&B .............................................................................................. $2,232,304,000 $2,414,728,159 $2,581,551,000 ..........................

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Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 36599

TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE—Continued
Fiscal year 2015 2016 2017 3-Year average

Total FTE ................................................................................................. 15,484 16,381 17,022 ..........................
PC&B per FTE ......................................................................................... $144,168 $147,408 $151,660 ..........................
Percent change from previous year ........................................................ 2.1136 2.2474 2.8845 2.4152

The payroll adjustment is 2.4152 Baltimore, DC–MD–VA–WV; Not Washington area. These data are
percent multiplied by 60 percent, or Seasonally Adjusted; All Items; Annual published by the Bureau of Labor
1.4491 percent. Index) for the first 3 of the preceding 4 Statistics and can be found on their
The statute specifies that the years of available data multiplied by website at: https://data.bls.gov/pdq/
component of the inflation adjustment 0.40, or 40 percent (see 21 U.S.C. SurveyOutputServlet?data_
for non-payroll costs for FY 2019 is the 379j(c)(2)(C)). tool=dropmap&series_
average annual percent change that Table 2 provides the summary data id=CUURA311SA0,CUUSA311SA0.
occurred in the Consumer Price Index and the 3-year average percent change
(CPI) for urban consumers (Washington- in the specified CPI for the Baltimore-

TABLE 2—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI
Fiscal year 2015 2016 2017 3-Year average

Annual CPI ............................................................................................... 155.353 157.180 159.202 ..........................
Annual Percent Change .......................................................................... 0.3268 1.1760 1.2864 ..........................
3-Year Average Percent Change in CPI ................................................. .......................... .......................... .......................... 0.9297

The non-pay adjustment is 0.9297 (rounded) for FY 2019. We then fees of $322,147 (premarket application)
percent multiplied by 40 percent, or multiply the total revenue amount for and $4,884 (establishment registration).
0.3719 percent. FY 2019 ($190,654,875) by 1.073823,
Next, the payroll adjustment (1.4491 B. Further Adjustments
yielding an inflation adjusted total
percent or 0.014491) is added to the revenue amount of $204,730,000 After the applicable inflation
non-payroll adjustment (0.3719 percent (rounded to the nearest thousand adjustment to fees is done, FDA may
or 0.003719), for a total of 1.8210 dollars). increase, if necessary to achieve the
percent (or 0.018210). To complete the inflation adjusted total revenue amount,
inflation adjustment, 1 (100 percent or III. Fees for FY 2019 the base fee amounts on a uniform
1.0) is added for a total base inflation Under the FD&C Act, all submission proportionate basis (see 21 U.S.C.
adjustment of 1.018210 for FY 2019. fees and the periodic reporting fee are 379j(c)(2)(D)(ii)). If necessary after this
MDUFA IV provides for this inflation set as a percent of the standard (full) fee adjustment, FDA may further increase
adjustment to be compounded for FY for a premarket application (see 21 the base establishment registration fees
2019 and each subsequent fiscal year U.S.C. 379j(a)(2)(A)). to generate the inflation adjusted total
(see 21 U.S.C. 379j(c)(2)(B)(ii)). The base revenue amount (see 21 U.S.C.
inflation adjustment for FY 2019 A. Inflation Adjustment
379j(c)(3)).
(1.018210) is compounded by MDUFA specifies that the base fees of
multiplying it by the compounded $300,000 (premarket application) and C. Calculation of Fee Rates
applicable inflation factor from FY 2018 $4,548 (establishment registration) are Table 3 provides the last 3 years of
(1.054618). To complete the to be adjusted for FY 2019 using the fee-paying submission counts and the 3-
compounded inflation adjustment for same methodology as that for the total year average. These numbers are used to
FY 2019, the FY 2018 compounded revenue inflation adjustment in section project the fee-paying submission
adjustment (1.054618) is multiplied by II (see 21 U.S.C. 379j(c)(2)(D)(i)). counts that FDA will receive in FY
the FY 2019 base inflation adjustment Multiplying the base fees by the 2019. Most of the fee-paying submission
(1.018210) to reach the applicable compounded inflation adjustment of counts are published in the MDUFA
inflation adjustment of 1.073823 1.073823 yields inflation adjusted base Financial Report to Congress each year.

TABLE 3—THREE-YEAR AVERAGE OF FEE-PAYING SUBMISSIONS
Application type FY 2015 actual FY 2016 actual FY 2017 actual 3-Year average

Full Fee Applications ....................................................... 42 37 40 40
Small Business ......................................................... 7 10 7 8
Panel-Track Supplement ................................................. 22 17 27 22
Small Business ......................................................... 3 1 2 2
daltland on DSKBBV9HB2PROD with NOTICES

De Novo Classification Request 1 .................................... ................................ ................................ 24 24
Small Business 1 ....................................................... ................................ ................................ 31 31
180-Day Supplements ..................................................... 143 116 184 148
Small Business ......................................................... 15 16 36 22
Real-Time Supplements .................................................. 204 179 195 193
Small Business ......................................................... 28 27 20 25
510(k)s ............................................................................. 2,768 2,599 3,141 2,836
Small Business ......................................................... 1,037 1,005 1,125 1,056

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36600 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices

TABLE 3—THREE-YEAR AVERAGE OF FEE-PAYING SUBMISSIONS—Continued
Application type FY 2015 actual FY 2016 actual FY 2017 actual 3-Year average

30-Day Notice .................................................................. 920 929 1,080 976
Small Business ......................................................... 71 76 82 76
513(g) (21 U.S.C. 360c(g)) Request for Classification
Information ................................................................... 75 68 98 80
Small Business ......................................................... 33 46 41 40
Annual Fee for Periodic Reporting 2 ................................ 554 582 429 522
Small Business 2 ....................................................... 73 75 37 62
Establishment Registration .............................................. 25,363 26,046 27,268 26,226
1 Three-year average for De Novo is based on estimate for FY 2019.
2 Includes collection of quarter 4 billing for FY 2017 during FY 2018.

The information in table 3 is (per calculations in section III.A.) adjusted total revenue amount. The fees
necessary to estimate the amount of (column two). Using the inflation in column two are those we are
revenue that will be collected based on adjusted fees and the 3-year averages of establishing in FY 2019, which are the
the fee amounts. Table 4 displays the FY fee paying submissions, collections are standard fees.
2019 base fees set in statute (column projected to total $207,708,611, which is
one) and the inflation adjusted base fees $2,978,611 higher than the inflation

TABLE 4—FEES NEEDED TO ACHIEVE NEW FY 2019 REVENUE TARGET
FY 2019
FY 2019 inflation FY 2019
Application type statutory fees adjusted revenue from
(base fees) statutory base fees adjusted fees
(standard fees)

Full Fee Applications ........................................................................................... $300,000 $322,147 $12,885,880
Small Business ............................................................................................. 75,000 80,537 644,296
Panel-Track Supplement ..................................................................................... 225,000 241,610 5,315,420
Small Business ............................................................................................. 56,250 60,403 120,806
De Novo Classification Request .......................................................................... 90,000 96,644 2,319,456
Small Business ............................................................................................. 22,500 24,161 748,991
180-Day Supplements ......................................................................................... 45,000 48,322 7,151,656
Small Business ............................................................................................. 11,250 12,081 265,782
Real-Time Supplements ...................................................................................... 21,000 22,550 4,352,150
Small Business ............................................................................................. 5,250 5,638 140,950
510(k)s ................................................................................................................. 10,200 10,953 31,062,708
Small Business ............................................................................................. 2,550 2,738 2,891,328
30-Day Notice ...................................................................................................... 4,800 5,154 5,030,304
Small Business ............................................................................................. 2,400 2,577 195,852
513(g) Request for Classification Information ..................................................... 4,050 4,349 347,920
Small Business ............................................................................................. 2,025 2,175 87,000
Annual Fee for Periodic Reporting ...................................................................... 10,500 11,275 5,885,550
Small Business ............................................................................................. 2,625 2,819 174,778
Establishment Registration .................................................................................. 4,548 4,884 128,087,784

Total .............................................................................................................. ................................ ................................ 207,708,611

The standard fee (adjusted base • For an annual fee for periodic (see 21 U.S.C. 379j(d)(2)(C) and
amount) for a premarket application, reporting concerning a class III device, (e)(2)(C)). For a 30-day notice, and a
including a BLA, and for a premarket 3.5 percent of the standard fee; 513(g) request for classification
report and a BLA efficacy supplement, • For a 510(k) premarket notification, information, the small business fee is 50
is $322,147 for FY 2019. The fees set by 3.4 percent of the standard fee; percent of the standard (full) fee for the
reference to the standard fee for a • For a 30-day notice, 1.6 percent of submission (see 21 U.S.C. 379j(d)(2)(C)).
premarket application are: the standard fee; and
• For a 513(g) request for The annual fee for establishment
• For a panel-track supplement, 75 registration, after adjustment, is set at
percent of the standard fee; classification information, 1.35 percent
$4,884 for FY 2019. There is no small
• For a de novo classification request, of the standard fee.
For all submissions other than a 30- business rate for the annual
30 percent of the standard fee;
• For a 180-day supplement, 15 day notice, and a 513(g) request for establishment registration fee; all
daltland on DSKBBV9HB2PROD with NOTICES

percent of the standard fee; classification information, the small establishments pay the same fee.
• For a real-time supplement, 7 business fee is 25 percent of the Table 5 summarizes the FY 2019 rates
percent of the standard fee; standard (full) fee for the submission for all medical device fees.

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Document Created: 2018-07-28 01:43:24
Document Modified: 2018-07-28 01:43:24

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		For information on Medical Device User Fees: Visit FDA's website at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ ucm20081521.htm.
FR Citation		83 FR 36598

83 FR 36598 - Medical Device User Fee Rates for Fiscal Year 2019

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 146 (July 30, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration