Form 3602 Medical Device User Fee

Guidance for Industry and Food
and Drug Administration Staff
and Foreign Governments FY
2012 Medical Device User Fee
Small Business Qualification
and Certification
Document issued on: May 25, 2012.

This document supersedes “Guidance for Industry, FDA, and Foreign
Governments: FY 2011 Medical Device User Fee Small Business
Qualification and Certification,” August 1, 2011.
OMB Control No. 0910-0508
Expiration Date: 2/28/2013
See additional PRA statement at the end of this guidance
For questions regarding this document contact CDRH’s Division of Small Manufacturers,
International and Consumer Assistance at 800-638-2041 or [email protected]; or CBER’s
Office of Communication, Outreach and Development at 1-800-835-4709 or 301-827-1800.
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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Preface
Public Comment
You may submit written comments and suggestions at any time for Agency consideration to the
Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room
1061, (HFA-305), Rockville, MD, 20852. Submit electronic comments to
www.regulations.gov. When submitting comments, please refer to the exact title of this
guidance document. Comments may not be acted upon by the Agency until the document is
next revised or updated.

Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request to
[email protected] to receive an electronic copy of the guidance or send a fax request to 301827-8149 to receive a hard copy. Please use the document number 2012 to identify the
guidance you are requesting.
Additional copies of this draft guidance are also available from CBER:
Office of Communication, Outreach and Development (OCOD) (HFM-40), 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-8271800, or by e-mail at [email protected] or from the Internet at
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
Guidances/ default.htm.

Additional Information About Medical Device User Fees
For additional information about medical device user fees, see FDA’s Medical Device User
Fees web site at —
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA
This site provides an overview of the laws establishing medical device user fees, links to
additional guidance documents, answers to frequently-asked questions, and more.

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Table of Contents
Guidance for Industry, FDA, and Foreign Governments:

FY 2012 Medical Device User Fee
Small Business Qualification and Certification

Contents
Introduction
I.

Benefits of Qualifying as a Small Business ...................................................4

II.

Guidance for U.S. Businesses........................................................................6

III.

Guidance for Foreign Businesses ..................................................................9

IV.

Guidance for Foreign Governments — Preparation of a National
Taxing Authority Certification ....................................................................11

V.

Frequently-asked Questions.........................................................................12

Appendix — Forms and Instructions ......................................................................15
·
·
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FY 2012 MDUFMA Small Business Qualification and Certification
FY 2012 MDUFMA Foreign Small Business Qualification and Certification
National Taxing Authorities known to FDA

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Guidance for Industry and
Food and Drug Administration Staff and
Foreign Governments
FY 2012 Medical Device User Fee
Small Business Qualification and
Certification
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.
It does not create or confer any rights for or on any person and does not operate to bind FDA or the
public. You can use an alternative approach if the approach satisfies the requirements of the
applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA
staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff,
call the appropriate number listed on the title page of this guidance.

Introduction
This guidance explains how your business may qualify as a “small business” and pay most FY 2012
medical device user fees at substantially discounted rates; if you qualify as a small business, you may
also qualify to obtain a one-time waiver of the fee for your first (ever) premarket application (premarket
approval application, biologics license application, product development protocol, or premarket report).
The standard and small business fees for FY 2012 are shown in the table on p. 5.
Your business may qualify as a small business if you reported “gross receipts or sales” of no more than
$100 million for the most recent tax year. If you have any affiliates, you must add their gross receipts or
sales to yours and the total must be no more than $100 million. Section I, Benefits of Qualifying as a
Small Business, and Section V, Frequently-asked Questions, provide information of general applicability.
If your business is headquartered in the United States, you should follow the guidance in Section II,
Guidance for U.S. Businesses, beginning at p. 6. You will complete an FY 2012 MDUFMA Small
Business Qualification and Certification, Form FDA 3602 (for FY 2012), and submit it to FDA for

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review; a copy of this form and instructions for its completion are provided in the Appendix. FDA will
review your Small Business Qualification Certification within 60 days of receipt.
If your business is a foreign business headquartered outside the United States, you should follow the
guidance in Section III, Guidance for Foreign Businesses, beginning at p. 9. To qualify as a small
business, you should complete Section I and II of an FY 2012 MDUFMA Foreign Small Business
Qualification and Certification, Form FDA 3602A (for FY 2012), and submit it first to your National
Taxing Authority (the equivalent of the U.S. Internal Revenue Service), and after the National Taxing
Authority has returned the form to you with Section III completed (providing a National Taxing
Authority Certification concerning your business), you should then submit the 3602A to FDA for
review; a copy of this form and instructions for its completion are provided in the Appendix. You
should also review Section IV, Guidance for Foreign Governments — Preparation of a National Taxing
Authority Certification, to understand the role played by your national taxing authority (particularly
regarding Section III of the 3602A, which provides the National Taxing Authority Certification
concerning the information you intend to submit to FDA). FDA will review your Small Business
Qualification Certification within 60 days of receipt.
If you are a National Taxing Authority, you should review the guidance provided in Section IV,
Guidance for Foreign Governments — Preparation of a National Taxing Authority Certification; you
will complete Section III, National Taxing Authority Certification, of each 3602A submitted to you by a
business headquartered in your nation, which you should return to the business seeking small business
status.

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Important Changes to the FY 2012 Guidance
This guidance is substantively the same as the guidance provided for FY 2011.
Where necessary, we have changed the dates cited throughout the guidance to reflect those that
apply to the new fiscal year. We have also updated the information on standard and small
business fees to reflect the new fee rates for FY 2012 (see the table on p. 5).
We have added contact information for each foreign National Taxing Authority known to
FDA; see What is my National Taxing Authority?, at p. 5 of the Instructions for Completing
Your FY 2012 MDUFMA Foreign Small Business Qualification Certification For a Business
Headquartered Outside the United States.
We have updated FDA telephone numbers and addresses throughout the guidance to reflect
relocation of some FDA operations.
Enactment of the Medical Device User Fee Amendments of 2007 (Title II of the Food and
Drug Administration Amendments Act of 2007 (“the 2007 Amendments”) created additional
types of fees and has led to several important changes in how you qualify as a small business.
The following considerations are particularly significant:
• The guidance explains that there is no small business discount for the establishment
registration fee. See Section I of the guidance, p. 4. If this is the only fee you expect to
pay during FY 2012, you should not submit an FY 2012 Small Business Qualification
Certification.
• A foreign business may qualify as a small business, even if you have not submitted a
Federal (U.S.) income tax return. See Section III, p. 9.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements are cited. The use of the word
should in Agency guidances means that something is suggested or recommended, but not required.

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I. Benefits of Qualifying as a Small Business
What are the benefits of qualifying as a small business under MDUFMA?
If you qualify as a small business, you will be able to pay significantly lower user fees than you would
otherwise pay:
•

You may pay reduced small business fees instead of the standard fees. If you qualify as a small
business, you will be eligible to pay a reduced fee for —
o each of your medical device submissions that is subject to a user fee;
o each of your class III devices that is subject to periodic reporting.
To pay a reduced small business fee, you must qualify as a small business with gross receipts or
sales of no more than $100 million, including the gross receipts or sales of all of your affiliates.
See sections 738(d)(2)(A) and 738(e)(2)(A) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act).

•

You may obtain a one-time waiver of the fee for your first (ever) premarket application
(premarket approval application, biologics license application, product development protocol, or
premarket report). To qualify for this fee waiver, you must qualify as a small business with gross
receipts or sales of no more than $30 million, including the gross receipts or sales of all of your
affiliates. See section 738(d)(1) of the FD&C Act.

Is there a reduced small business fee for the new establishment registration fee? No. Every
establishment that is subject to the registration fee will pay the same fee. If the registration fee is the
only fee you expect to pay during FY 2012, you should not submit an FY 2012 Certification.
What are the standard and small business fees for FY 2012? The fees for FY 2012 are shown in the
following table, and are set by law. If your submission is subject to a fee, the law requires you to pay the
standard fee unless FDA determines you qualify as a small business. If you qualify as a small business
for FY 2012, you are eligible to pay a reduced fee for any submissions or reporting from the date of
FDA’s determination through the end of FY 2012.

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Medical Device Fees for FY 2012
Fees Relating to Medical Device Applications
Application Type

Standard Fee

Small Business

Premarket Application (PMA, BLA, PDP)

$220,050

$55,013

Premarket report (for a reprocessed single-use device)

$220,050

$55,013

Panel-track PMA supplement

$165,038

$41,259

BLA efficacy supplement

$220,050

$55,013

180-day PMA supplement

$33,008

$8,252

Real-time PMA supplement

$15,404

$3,851

510(k) premarket notification

$4,049

$2,024

30-day notice

$3,521

$1,760

513(g) request for classification information

$2,971

$1,485

Annual fee for periodic reporting on a class III device

$7,702

$1,925

Establishment Registration Fee — There is no reduced fee for a small business. If this is the
only fee you expect to pay during FY 2012, you should not submit an FY 2012 Certification.
Type of Fee
Establishment registration fee

Annual Fee
$2,029

Who can qualify as a small business under MDUFMA? Both domestic (U.S.) and foreign businesses
may qualify as a small business. For FY 2012, you can qualify for small business fee discounts if you
reported gross receipts or sales of no more than $100 million for the most recent tax year. If you have
any affiliates, you must add their gross receipts or sales to yours and the total must be no more than $100
million. See sections 738(d)(2)(A) and 738(e)(2)(A) of the FD&C Act. If your gross receipts or sales
are no more than $30 million (including the gross receipts or sales of all of your affiliates), you will also
qualify for a waiver of the fee for your first (ever) premarket application (PMA, BLA, PDP, or
Premarket Report). See section 738(d)(1) of the FD&C Act.
How can I obtain an FDA decision that I am a small business for FY 2012? The qualification
process depends on whether you are a domestic (U.S.) or foreign business:

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•

•

If you are a domestic business headquartered in the United States, you should submit an FY 2012
MDUFMA Small Business Qualification Certification (Form FDA 3602) and copies of your
most-recent Federal (U.S.) income tax returns directly to FDA. You should also submit a
Federal (U.S.) income tax return or an FY 2012 MDUFMA Foreign Small Business Qualification
Certification for each of your affiliates. See Section III, p. 9.
If your business is headquartered in a foreign country, you will first submit your evidence of
qualification to the National Taxing Authority of the country in which you are headquartered.
The National Taxing Authority is responsible for determining your gross receipts or sales in U.S.
dollars and will provide the National Taxing Authority Certification that you will send to FDA as
part of your FY 2012 MDUFMA Foreign Small Business Qualification Certification. You
should also submit a Federal (U.S.) income tax return or an FY 2012 MDUFMA Foreign Small
Business Qualification Certification for each of your affiliates. See Section III, p. 9.

When does my premarket application qualify for the “first premarket application” fee waiver?
There are two important considerations here. First, your gross receipts or sales (including your affiliates)
must be no more than $30 million. See section 738(d)(1) of the FD&C Act. This means that some firms
that do qualify for small business fee discounts (because their gross receipts or sales are less than $100
million) will not qualify for the “first premarket application” fee waiver (because their gross receipts or
sales are more than $30 million).
Second, you should count prior premarket applications made by your affiliates when determining
whether a premarket application is your “first.” If you or any affiliate previously submitted a premarket
application, your application does not qualify for the fee waiver, and you must pay the fee that would
otherwise apply.

II. Guidance for U.S. Businesses
A U.S. business is a business headquartered in the United States. If you are a U.S. business, you should
follow the guidance provided in this section. If your business is headquartered in a foreign country, you
should follow the guidance in Section III., Guidance for Foreign Businesses.
If you believe you qualify as a small business and want to pay reduced or waived fees, you should submit
an FY 2012 MDUFMA Small Business Qualification Certification, Form FDA 3602 (for FY 2012), with
your Federal income tax return for the most recent tax year, and the Federal income tax returns of each
of your affiliates for the most recent tax year. FDA will review your Certification and Federal income
tax returns within 60 days and will send you our decision that you are, or are not, a small business
eligible for reduced or waived fees for submissions you make during FY 2012 (submissions received by
FDA from October 1, 2011 through September 30, 2012). If we decide you are a small business, our
decision letter will assign you a Small Business Decision number. You should provide this number to

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FDA each time your want to receive a small business fee discount for a premarket submission or when
you want to obtain a fee waiver for your first premarket application.
What is an affiliate? This term is defined by section 737(12) of the FD&C Act. Affiliate means a
business entity that has a relationship with a second business entity if, directly or indirectly —
(a) one business entity controls, or has the power to control, the other business entity;
or
(b) a third party controls, or has power to control, both of the business entities.
You must include the gross receipts or sales of all of your affiliates with your own gross receipts or sales
when you prepare your Medical Device User Fee Small Business Qualification Certification. See
sections 738(d)(2)(A) and 738(e)(2)(A) of the FD&C Act.
Why does FDA require me to submit Federal (U.S.) income tax returns? Sections 738(d)(2)(B) and
738(e)(2)(B) of the FD&C Act require an applicant to pay the standard fees for its submissions unless it
demonstrates it is a small business by submitting a copy of its most recent Federal income tax returns
(and returns of all affiliates). A consequence of this requirement is that you cannot qualify as a small
business under MDUFMA if you have not submitted a Federal income tax return. Until you file a
Federal income tax return, you can not qualify as a small business and, therefore, the law requires you to
pay the standard fee for any medical device application you submit that is subject to a fee. FDA cannot
accept a foreign tax return in place of a Federal (U.S.) income tax return.
What is the most recent tax year? The most recent tax year will be 2011, except —
• If you submit your FY 2012 MDUFMA Small Business Qualification before April 15, 2012 and
you have not yet filed your return for 2011, you may use tax year 2010.
• If you submit your FY 2012 MDUFMA Small Business Qualification after April 15, 2012 and
you have not yet filed your 2011 return because you obtained an extension, you may use your
most-recent return filed prior to the extension.
My organization filed a Form 990, Return of Organization Exempt from Income Tax. Do I still
need to qualify as a Small Business? Yes. The FD&C Act does not exempt you from medical device
user fees or grant you automatic small business status simply because you are exempt from Federal
income tax. You are subject to the same “gross receipts or sales” thresholds as other applicants. You
should report your Total Revenue (line 12 of Form 990) as your “gross receipts or sales.”
May I submit a foreign income tax return to show I am a small business? No. Under the law, if
your business is headquartered in the United States, you must support your claim that you qualify as a
small business “by submission of a copy of [your] most recent Federal income tax return for a taxable
year, and a copy of such returns of [your] affiliates . . . .” If your business is headquartered in the United
States and you have not filed a Federal (U.S.) income tax return, you cannot qualify as a small business

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under MDUFMA. See sections 738(d)(2)(B) and 738(e)(2)(B) of the FD&C Act. If you have a foreign
affiliate, you should submit a separate FY 2012 Foreign Small Business Qualification Certification
(which includes a National Taxing Authority Certification) for that affiliate; see section III for guidance
concerning foreign businesses.
Where can I obtain a copy of the FY 2012 Medical Device User Fee Small Business Qualification
Certification form? A copy is included in the Appendix of this guidance. The form is not available as a
separate document. You may print the pages that include the form, and then complete it by hand or by
typewriter. If you download the PDF (portable document format) version of this guidance, you can fill
in the form using your PC and then print it. The PDF version of this guidance is available on the Internet
at —
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA
The information you enter on the PDF version of the Certification form is not saved on your PC and is
not sent to FDA. You will not be able to “retrieve” or “open” your completed Certification at a later
time. After you complete the electronic version of the Certification, you will need to print the form, sign
it, date it, and send in to FDA with your supporting Federal income tax returns.
Where do I send my completed FY 2012 MDUFMA Small Business Qualification Certification and
supporting materials?
Send your completed Certification and all supporting documentation to:
FY 2012 MDUFMA Small Business Qualification
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Avenue
Building 66, Room 4613
Silver Spring, MD 20993

Be sure to include copies of all of Federal income tax returns and certifications from foreign national
taxing authorities that relate to your Certification.

III. Guidance for Foreign Businesses
A Foreign business is a business headquartered outside the United States. If you are a Foreign business,
you should follow the guidance provided in this section. If your business is headquartered in the United
States, you should follow the guidance in Section II, Guidance for U.S. Businesses.
If you are a Foreign business, you should complete Sections I and II of an FY 2012 MDUFMA Foreign
Small Business Qualification Certification and you should then submit your Certification and supporting

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evidence of qualification to your National Taxing Authority (the equivalent of the United States Internal
Revenue Service). Your National Taxing Authority should complete Section III, National Taxing
Authority Certification, and should return your completed FY 2012 MDUFMA Foreign Small Business
Qualification Certification to you. You should then send the completed Certification to FDA.
FDA will review your Certification and supporting evidence within 60 days and will send you our
decision that you are, or are not, a small business eligible for reduced or waived fees for submissions you
make during FY 2012 (submissions received by FDA from October 1, 2011 through September 30,
2012). If we decide you are a small business, our decision letter will assign you a Small Business
Decision number. You will need to provide this number to FDA each time you want to receive a small
business fee discount for a premarket submission or when you want to obtain a fee waiver for your first
premarket application.
What is an affiliate? This term is defined by section 737(12) of the FD&C Act. Affiliate means a
business entity that has a relationship with a second business entity if, directly or indirectly —
(a) one business entity controls, or has the power to control, the other business entity;
or
(b) a third party controls, or has power to control, both of the business entities.
You must include the gross receipts or sales of all of your affiliates with your own gross receipts or sales
when you prepare your Medical Device User Fee Small Business Qualification Certification.
How do I contact my National Taxing Authority? You should contact the government agency that
collects your national income tax. FDA does not have a complete list of every National Taxing
Authority, but as we obtain authoritative information from foreign governments, we will post contact
information on our MDUFMA web site at —
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserF
eeandModernizationActMDUFMA.
If we have not posted contact information for your National Taxing Authority, it is your responsibility to
identify the appropriate point of contact. This information is subject to change, and it is also your
responsibility to verify that the contact information remains correct.
May a foreign applicant file a Federal (U.S.) income tax return in order to qualify as a small
business under MDUFMA? FDA expects nearly all foreign businesses will not submit a Federal
income tax return, but will instead submit an FY 2012 Foreign Small Business Qualification
Certification, and a National Taxing Authority Certification. Although the law does not prohibit a
foreign business from submitting a Federal income tax return, filing a Federal income tax return may
have significant tax and other legal consequences beyond simply making you eligible as a small business
under MDUFMA. FDA cannot provide advice concerning whether you should or should not file a

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Federal income tax return. If you are in doubt as to whether it is advisable for you to file a Federal
income tax return, you should consider consulting with qualified legal and tax professionals. Additional
information on Federal income taxation is available from the United States Internal Revenue Service
(www.irs.gov).
Where can I obtain a copy of the FY 2012 MDUFMA Foreign Small Business Qualification
Certification form? A copy is included in the Appendix of this guidance. The form is not available as
a separate document. You may print the pages that include the form, and then complete it by hand or by
typewriter. If you download the PDF (portable document format) version of this guidance, you can fill
in the form using your PC and then print it. The PDF version of this guidance is available on the Internet
at —
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA.
The information you enter on the PDF version of the Certification form is not saved on your PC and is
not sent to FDA. You will not be able to “retrieve” or “open” your completed Certification at a later
time. After you complete the electronic version of the Certification, you should print the form, sign it,
date it, and send it to your National Taxing Authority with any additional information or materials
required by the National Taxing Authority.
Your National Taxing Authority should complete Section III, National Taxing Authority Certification,
and you should then send your completed FY 2012 MDUFMA Foreign Small Business Qualification
Certification and supporting evidence to FDA.
Where do I send my completed FY 2012 MDUFMA Foreign Small Business Qualification
Certification and supporting materials?
After your National Taxing Authority has completed Section III and returned the completed Certification
to you, you should send your FY 2012 MDUFMA Foreign Small Business Qualification Certification
and all supporting documentation to:
FY 2012 MDUFMA Foreign Small Business Qualification
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Avenue
Building 66, Room 4613
Silver Spring, MD 20993
United States of America

IV. Guidance for Foreign Governments — Preparation of a
National Taxing Authority Certification

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Qualification as a MDUFMA small business allows the business to pay reduced medical device user
fees; some small businesses may also qualify to obtain a waiver of the fee for its first premarket
application. Prior to enactment of the Medical Device User Fee Amendments of 2007, very few foreign
businesses could qualify as a small business under MDUFMA because the law required the business to
submit a Federal (U.S.) income tax return as the only acceptable evidence that its “gross receipts or
sales” did not exceed $100 million.
The Medical Device User Fee Amendments of 2007 provide an alternative means for a foreign business
to demonstrate that it qualifies as a MDUFMA small business. Instead of providing a Federal (U.S.)
income tax return, a foreign business may now obtain a certification from its “National Taxing
Authority” showing that its gross receipts or sales do not exceed the $100 million qualification
threshold. The law requires that this certification, referred to as the “National Taxing Authority
Certification,” must —
•
•
•

•
•

be in English;
be from the National Taxing Authority of the country in which the business is headquartered;
provide the business’s gross receipts or sales for the most recent year, in both the local currency
and in United States dollars, and the exchange rate used in converting local currency to U.S.
dollars;
provide the dates during which the reported receipts or sales were collected; and
bear the official seal of the National Taxing Authority.

See sections 738(d)(2)(B)(iii) and 738(e)(2)(B)(iii) of the FD&C Act.
The FY 2012 MDUFMA Foreign Small Business Qualification Certification, Form FDA 3602A (for
FY 2012), provides space for this required information in Section III — National Taxing Authority
Certification.
May the National Taxing Authority Certification be provided in any language other than English?
No. Sections 738(d)(2)(B)(iii)(II) and 738(e)(2)(B)(iii)(II) of the FD&C Act require the certification to
be in English.
What are “gross receipts or sales”? If you are unsure how “gross receipts or sales” relates to your
national income taxation system, please contact the United States Internal Revenue Services through the
United States Embassy.

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What information should the business submit to the National Taxing Authority?
The business should provide an FY 2012 MDUFMA Foreign Small Business Qualification Certification,
with Section I and II completed. Each National Taxing Authority may require the business to provide
additional information and evidence needed by the National Taxing Authority to determine the gross
receipts or sales it will report in the National Taxing Authority Certification for the business.
What exchange rate should be used to convert local currency to U.S. dollars?
You should use the exchange rate in effect as of the ending date of the period during which the reported
receipts or sales were collected; this is the date shown in response to item 5.b. of the National Taxing
Authority Certification. FDA cannot provide this information to you; each National Taxing Authority is
responsible for determining the appropriate exchange rate to use.
Why does FDA require the National Taxing Authority Certification to bear the official seal of the
National Taxing Authority?
This is a statutory requirement. Sections 738(d)(2)(B)(iii)(II) and 738(e)(2)(B)(iii)(II) of the FD&C Act
require the National Taxing Authority Certification to bear the official seal of the National Taxing
Authority.

V. Frequently-asked Questions
What is the purpose of a Small Business Decision number? You should use your Small Business
Decision number to demonstrate that you have qualified as a small business for FY 2012. For example,
whenever you submit a Medical Device User Fee Cover Sheet (Form FDA 3601), you should provide
your Small Business Decision number. This will allow FDA to quickly confirm that you are entitled to a
reduced or waived fee.
When will my status as a small business begin? Your status as a small business will begin as of the
date of FDA’s decision letter finding that you qualify as a small business. FDA expects to make its
decision within 60 days of receiving your Certification and supporting materials.
What fee should I pay if I submit an application before FDA determines that I qualify as a small
business? If you submit an application before FDA has determined you qualify as a small business, you
should pay the standard (full) amount of any fee that applies. FDA will not refund the difference
between the standard (full) fee and the small business fee if you later qualify as a small business. If you
want to pay the small business fee for an application, you should not submit your application until you
obtain your Small Business Decision number from FDA.

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When will my status as a small business expire? Your status as a small business will expire on
September 30, 2012. You should submit a new MDUFMA Small Business Qualification Certification
each year to qualify as a small business. This is because —
•
•

Your “gross sales and receipts” will vary from one year to another.
We will always need a copy of your most recent Federal income tax return (if your are a U.S.
business) or your most recent certification of income from your national taxing authority (if you
are a foreign business).

Can I be certain FDA will protect my income tax returns and other financial information? Yes.
Your income tax returns and other financial information are “confidential commercial information” and
will not be released to the public.
What may happen if I submit a false certification concerning my business? When you make your
certification, you are explicitly certifying:
“. . . to the best of my knowledge, the information I have provided in this Certification is
complete and accurate. I understand that submission of a false certification may subject me
to criminal penalties under 18 U.S.C. § 1001 and other applicable federal statutes.”
This statement appears immediately above your signature.
A false certification is one where you report information that is not true (for example, your gross receipts
or sales are actually higher than you state) or if you fail to disclose required information (for example,
you fail to disclose the existence of a parent, partner, or affiliate).
If FDA determines you submitted a false certification, we may suspend your status as a Small Business,
we may suspend the review of any application you submitted until you pay the full fee that applies to that
type of application, we may seek payment of the unpaid portion of fees that should have been paid, we
may take other legal actions that are appropriate under the circumstances, and you may be subject to
criminal penalties under 18 U.S.C. § 1001 and other applicable federal statutes.
If I have a question, who can I call? If you need additional information about becoming a MDUFMA
small business, contact FDA’s Division of Small Manufacturers, International, and Consumer Assistance
at 800-638-2041 or 301-796-7100.

FY 2012 MDUFMA Small Business Qualification and Certification

13

Contains Nonbinding Recommendations

Appendix — Forms and Instructions
This appendix provides —
•

FY 2012 MDUFMA Small Business Qualification Certification, Form FDA 3602 (for FY
2012). You should use this form if your business is headquartered in the United States.
Instructions are provided immediately after the form.

•

FY 2012 MDUFMA Foreign Small Business Qualification Certification, Form FDA 3602A
(for FY 2012). You should use this form if your business is headquartered outside the United
States. Instructions are provided immediately after the form.

•

A list of National Taxing Authorities known to FDA. This information will help foreign
applicants identify and contact the appropriate National Taxing Authority responsible for
completion of Section III — National Taxing Authority Certification of the FY 2012 MDUFMA
Foreign Small Business Qualification Certification, Form FDA 3602A (for FY 2012).

You may print whichever form you need, and then complete it by hand or by typewriter. If you
download the PDF (portable document format) version of this guidance, you can fill in the form using
your PC and then print it (see below for an instruction). The PDF version of this guidance is available
on the Internet at —
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA
Instruction: Download the guidance by visiting above link; Save it as a PDF file onto your computer;
Open the saved PDF file on your computer; Go to page 18 (for domestic firms) or page 25 (for foreign
firms); Go to the top right side of the page and Select “Tool”; Click on “Content”; Click on “Add or
Edit Text Box”. You can now able to type directly onto the form and print it when completed.
The information you enter on the PDF version of the Certification form is not saved on your PC and is
not sent to FDA. You will not be able to “retrieve” or “open” your completed Certification at a later
time. After you complete the electronic version of the Certification, you should print the form, sign it,
date it, and send in to FDA with your supporting Federal income tax returns.

FY 2012 MDUFMA Small Business Qualification and Certification

14

FY 2012 MDUFMA Small Business
Qualification Certification
For a Business Headquartered in the United States

OMB No. 0910-0508
Expiration Date: February 28, 2013
OMB Statement: See last page.

Section I — Information about the Business Requesting Small Business Status
1. Name of business claiming MDUFMA Small Business status:

2. Federal Employer Identification Number:

3. Address where business is physically located:

4. Name of person making this Certification:

5. Your telephone number:
(

)
Area Code

6. Your mailing address:

□ Check ( ) if same as item 3.

Telephone Number

7. Your e-mail address:

8. What is your relation to the business claiming MDUFMA Small Business status?

9. Have you listed all of the business’s affiliates in Section II of this form?
Check ( ) one response:

□ Yes

□ This business has no affiliates.

10. Complete, sign, and date the following certification:
I certify that
Name of business (must be identical to response to item 1)

(Check one response:)
□ has no affiliates and reported “gross receipts or sales” of no more than $100,000,000 on its most recent
Federal income tax return. I have attached a true and accurate copy of the business’s most recent Federal
income tax return.
□ has only the affiliates listed in this Certification, and together with those affiliates reported total “gross
receipts or sales” of no more than $100,000,000 for the most recent tax year. I have attached a true and
accurate copy of the entity’s most recent Federal income tax return, and a true and accurate copy of the most
recent Federal income tax return, or an FY 2012 Foreign Small Business Qualification Certification, for each
of the entity’s affiliates.
I further certify that, to the best of my knowledge, the information I have provided in this Certification is complete and
accurate. I understand that submission of a false certification may subject me to criminal penalties under 18 U.S.C.
§ 1001 and other applicable federal statutes.
Signature of person making this Certification:
Signature (must be signed by the person identified in item 4)

Date of this Certification:

Form FDA 3602 (for FY 2012)

Section II — Information about Your Affiliates
a. Name of Affiliate

b. Taxpayer ID Number

c. Gross Receipts or Sales

1

$

2

$

3

$

4

$

5

$

6

$

7

$

8

$

9

$

10

$

11

$

12

$

13

$

14

$

15

$

16

$

17

$

18

$

19

$

20

$

21

Total Gross Receipts and Sales of All Affiliates (sum of lines 1 through 20) $

22

Gross Receipts and Sales of the Business Making this Certification $

23

Total Gross Receipts and Sales Used to Determine Qualification as a Small Business $
(sum of lines 21 and 22)

(FDA Use Only)
Mail your completed FY 2012 Small Business Qualification Certification and
copies of your latest Federal income tax return to the address below. You
Review:
□ Information verified
must also send a separate FY 2012 Small Business Qualification Certification or
□ Information not verified
U.S. Federal income tax return or for of each of your affiliates. Send all materials Decision: □ Qualifies for Small Business fee discounts
to —
□ Qualifies for Small Business fee discounts and
FY 2012 MDUFMA Small Business Qualification
fee waiver for first premarket application
Division of Small Manufacturers, International, and Consumer Assistance
SBD12
10903 New Hampshire Avenue
□ Does not qualify
Building 66, Room 4613
Silver Spring, MD 20993
OMB Statement. The public reporting burden for this collection of information is estimated to
average 1 hour per response, including the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding this burden estimate or another aspect of this collection of
information, including suggestions for reducing this burden to:

U.S. Food and Drug Administration
Forms Comments
10903 New Hampshire Avenue
Building 66, Room 4613
Silver Spring, MD 20993
United States of America

An agency may not conduct or sponsor, and a
person is not required to respond to, a
collection of information unless it displays a
currently valid Office of Management and
Budget (OMB) control number.

Contains Nonbinding Recommendations

Instructions for Completing Your

FY 2012 MDUFMA Small Business Qualification Certification
For a Business Headquartered in the United States
Form FDA 3602
You should complete and submit an FY 2012 MDUFMA Small Business Qualification
Certification (Form FDA 3602) if you wish to be eligible for reduced or waived fees for medical
device submissions you make during FY 2012 (submissions received by FDA from October 1,
2011 through September 30, 2012). You should also submit —
•
•

a copy of your most recent Federal (U.S.) income tax return, and
if you have any affiliates —
o a copy of the most recent Federal income tax return of each of your domestic
(U.S.) affiliates, and
o a copy of an FY 2012 MDUFMA Foreign Small Business Qualification
Certification for each of your foreign affiliates.

See sections 738(d)(2) and 738(e)(2) of the Act.
FDA will use these materials to decide whether you qualify as a small business within the
meaning of MDUFMA.
You should mail your FY 2012 MDUFMA Small Business Qualification Certification, and
copies of the Federal income tax returns that support your Certification, to FDA at this
address —
FY 2012 MDUFMA Small Business Qualification
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Avenue
Building 66, Room 4613
Silver Spring, MD 20993

If you need assistance, please contact the Division of Small Manufacturers, International and
Consumer Assistance at 800-638-2041 or 301-796-7100.

Section I — Information about the Business Requesting Small Business Status
1. Name of business claiming MDUFMA Small Business status. Provide the full legal

name of the business –

Instructions — FY 2011 MDUFMA Small Business Qualification Certification (U.S.)

1

Contains Nonbinding Recommendations
•

If the business is a corporation, limited liability company, partnership, or other legal
entity, provide the name used in its articles of incorporation, articles of organization,
partnership registration, or other similar instrument filed with the State or other
government under whose laws the firm was created.

•

If the business is a sole proprietorship owned entirely by one individual, provide the name
used when filing Federal, State, or other taxes.

2. Federal Employer Identification Number. Your business’s Federal Employer
Identification Number (EIN) was assigned to you by the U.S. Internal Revenue Service and
uniquely identifies your business.
3. Address where business is physically located. This is the address where the business is

physically located (the address you would give to a person who needed to travel directly to the
business’s primary establishment).
4. Name of person making this Certification. This is the person who is responsible for the

accuracy and completeness of the information provided in the Certification and who must sign
the Certification (see item 10).
5. Your telephone number. This is the telephone number where FDA can reach you if we

have a question concerning your FY 2012 MDUFMA Small Business Qualification Certification.
6. Your mailing address. This is the address to which you want FDA to send its decision letter

informing you that you are, or are not, a small business. If your mailing address is the same as
item 3, you can just check the box rather than repeating the information.
7. Your e-mail address. This is the e-mail address where FDA can reach you if we have a

question concerning your FY 2012 MDUFMA Small Business Qualification Certification.
8. What is your relation to the business claiming MDUFMA Small Business status?
Briefly explain your position within the business (e.g., Chief Financial Officer; Vice President;
Chief Counsel; or other relationship that gives you authority to provide an FY 2012 MDUFMA
Small Business Qualification Certification on behalf of the business).
9. Have you listed all of the business’s affiliates in Section II of this form? If you have
any affiliates, check the first box (“Yes”) and list them in Section II of the form. If you do not
have any affiliates, check the second box (“This business has no affiliates.”).

Instructions — FY 2011 MDUFMA Small Business Qualification Certification (U.S.)

2

Contains Nonbinding Recommendations
10. Complete, sign, and date the following certification. In this certification, should provide
the following information:
•

The name of the business that is claiming MDUFMA small business status. This should
be identical to your response to item 1.

•

Check one response to indicate whether the business has any affiliates —
o Check the first box if the business has no affiliates.
o Check the second box if the business has only the affiliates you listed in Section II
of the form.

•

Check one response to indicate how the business determined it met the requirement that it
have “gross receipts or sales” of no more than $100 million —
o Check the first box if the entity reported “gross receipts or sales” of no more than
$100 million on its most recent Federal income tax return. Attach a true and
accurate copy (a complete and unaltered copy) of the business’s most-recent
Federal (U.S.) income tax return. FDA cannot accept a foreign tax return instead
of a Federal (U.S.) income tax return.
Where do I find my gross receipts or
sales? You reported your gross receipts
or sales on your most recent Federal
income tax return.
IRS Form
Schedule C
(Form 1040)
Schedule C-EZ
(Form 1040)
Form 1065
Form 1065-B
Form 1120
Form 1120-F
Form 1120S
Form 990
Any other form

What is the most recent tax year?
The most recent tax year will be
2011, except —
•

If you submit your FY 2012
MDUFMA Small Business
Qualification before April 15,
2012 and you have not yet
filed your return for 2011,
you may use tax year 2010.

•

If you submit your FY 2012
MDUFMA Small Business
Qualification on or after
April 15, 2012 and have not
yet filed your 2011 return
because you obtained an
extension, you may submit
your most-recent return filed
prior to the extension.

See Line
Number
1
1
1a
1a
1a
Section II, 1a
1a
12
Please contact
FDA.

Instructions — FY 2011 MDUFMA Small Business Qualification Certification (U.S.)

3

Contains Nonbinding Recommendations
o Check the second box if the business
and all of its affiliates together
reported “gross receipts or sales” of no
more than $100 million on their most
recent Federal income tax returns. You
should attach a true and accurate copy
(a complete and unaltered copy) of the
entity’s most recent Federal income tax
return and a true and accurate copy of
each affiliate’s most recent Federal
income tax return.

What is an affiliate? This term is
defined by § 737(12) of the Federal
Food, Drug, and Cosmetic Act.
Affiliate means a business entity that
has a relationship with a second
business entity where, directly or
indirectly —
(a) one business entity
controls, or has the power to
control, the other business
entity; or
(b) a third party controls, or
has power to control, both of

•

The person identified in item 4 (“Name of
person making this Certification”) must sign
the Certification.

•

Date the Certification (this is the date you signed the Certification).

the business entities.

Section II — Information about Your Affiliates
Section II of the form provides space for listing up to 20 affiliates; if you have more than 20
affiliates, you may provide the additional information on one or more additional copies of
Section II.
Lines 1 through 20 —
List each affiliate on a separate line. For each, you should provide the following information —
a. Name of Affiliate. Provide the full legal name of the affiliate –
•

If the affiliate is a corporation, limited liability company, partnership, or other legal
entity, you should provide the name used in its articles of incorporation, articles of
organization, partnership registration, or other similar instrument filed with the State
or other government under whose laws the firm was created.

•

If the affiliate is a sole proprietorship (that is, it is owned by an individual), you
should provide the name used when filing Federal, State, or other taxes.

Instructions — FY 2011 MDUFMA Small Business Qualification Certification (U.S.)

4

Contains Nonbinding Recommendations
b. Taxpayer ID Number. This number uniquely identifies each business —
•

•

If the affiliate is headquartered in the United States, you should provide the Employer
Identification Number (EIN) assigned to the affiliate by the U.S. Internal Revenue
Service.
If the affiliate is headquartered outside the United States, you should provide the
Taxpayer Identification Number provided by the National Taxing Authority where the
affiliate has its headquarters.

c. Gross Receipts or Sales. For each affiliate headquartered in the United States, you
should copy this number from the most-recent Federal income tax return for the affiliate. See
the instruction for item 9 to learn where you will find this information on a Federal income
return. For each affiliate headquartered outside the United States, you should copy the
information from item 3.b. of the National Taxing Authority Certification for the affiliate.
21. Total Gross Receipts and Sales of All Affiliates. This is the sum of the Gross Receipts
or Sales shown in column c. of lines 1 through 20.
22. Gross Receipts and Sales of the Business Making this Certification. This is the gross
receipts or sales of the business identified in Section I, item 1.
23. Total Gross Receipts and Sales Used to Determine Qualification as a Small
Business. This is the sum of lines 21 and 22. To qualify as a MDUFMA small business fee
discounts, this sum must be no more than $100 million. See sections 738(d)(2)(A) and
738(e)(2)(A) of the Act.

Instructions — FY 2011 MDUFMA Small Business Qualification Certification (U.S.)

5

Contains Nonbinding Recommendations

FY 2012 MDUFMA Foreign Small Business
Qualification Certification
For a Business Headquartered Outside the United States

OMB No. 0910-0508
Expiration Date: February 28, 2013
OMB Statement: See last page.

Section I — Information about the Business Requesting Small Business Status
1. Name of business requesting MDUFMA Small Business status:

2. Taxpayer Identification Number:

3. Address where business is physically located:
5. Your telephone number:

4. Name of person making this Certification:
Check ( ) one response: □ Head of Firm

□ Chief Financial Officer

6. Your mailing address:

□ Check ( ) if same as item 3.

7. Your e-mail addr□esCs:heck ( ) if same as item 3.

Section II — Information about Your Affiliates
a. Name of Affiliate

b. Taxpayer ID Number

c. Gross Receipts or Sales

1.

$

2.

$

3.

$

4.

$

5.

$

6.

$

7.

$

8.

$

9.

$

10.

$

11.

Total Gross Receipts and Sales of All Affiliates (sum of lines 1 through 10)

$

12.

Gross Receipts and Sales of the Business Making this Certification

$

13. Total Gross Receipts and Sales Used to Determine Qualification as a Small Business
(sum of lines 11 and 12)

$

14. Have you attached a separate FY 2012 MDUFMA Foreign Small Business Qualification Certification or
a U.S. Federal income tax return for each of your affiliates?
Check ( ) one response:

□ Yes

□ This business has no affiliates.

15. Complete, sign, and date the following certification:
I certify that
Name of business (must be identical to response to item 1)

(Check one response:)
□ has no affiliates and reported “gross receipts or sales” of no more than $100,000,000 (in U.S. dollars) in its most recent tax year.
□ has only the affiliates listed in this Certification, and together with those affiliates reported total “gross receipts or sales” of no more than
$100,000,000 (in U.S. dollars) in its most recent tax year.
I further certify that, to the best of my knowledge, the information I have provided in this Certification is complete and accurate. I understand that
submission of a false certification may subject me to criminal penalties under 18 U.S.C. § 1001 and other applicable federal statutes.

Signature:

Date signed:
(Signature of the person identified in item 4)

Form FDA 3602A (for FY 2012)

Contains Nonbinding Recommendations
Section III — National Taxing Authority Certification
This Certification Must be Completed by the National Taxing Authority
1. Name of business:
2. This business is: Check ( ) one response
□ The business requesting small business status. (All of Section I must be completed.)
□ An affiliate of a business requesting small business status. (Items 1 and 2 of Section I must be completed.)
3. Gross receipts or sales reported to the National Taxing Authority 4. Does the National Taxing Authority know
for the most recent tax year:
of any affiliate(s) of the business requesting
Currency Unit
Amount Reported small business status, other than those listed in
Section II?
a. Local currency:
Check ( ) one response:
b. U.S. currency:
U.S. Dollars
$
□ No (or not applicable).
c. Exchange rate (per U.S. Dollar):
□ Yes. An explanation is attached.
5. Period during which reported receipts or sales were collected:
a. Starting date:
b. Ending date:
Month-Day-Year

Month-Day-Year

6. a. Name of National Taxing Authority official making
this Certification:

7. Your telephone number:
8. Your e-mail address:

b. Your title:
9. Name of this National Taxing Authority:

10. Sign and date the following certification:

Affix Official Seal of National Taxing Authority here:

I certify that, to the best of my knowledge, the information I have
provided in this Certification is complete and accurate.
Signature of official making this Certification (must be signed by the official identified in item 6)

Date of this Certification:
The business seeking small business status should mail its completed FY 2012 Small Business
Qualification Certification to FDA at the address below. Your Certification is not complete and will
not be accepted unless Section III has been completed by your National Taxing Authority. If your business
has any affiliates, you must also send a separate FY 2012 Small Business Qualification Certification or
U.S. Federal income tax return for each affiliate. Send all materials to —
FY 2012 MDUFMA Small Business Qualification
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Avenue
Building 66, Room 4613
Silver Spring, MD 20993 United States of America
OMB Statement. The public reporting burden for this collection of information is estimated to
average 1 hour per response, including the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding this burden estimate or another aspect of this collection of
information, including suggestions for reducing this burden to:

(U.S. FDA Use Only)
Review:

□ Certification is complete.
□ Information not complete.

Decision:

□ Qualifies for Small Business fee discounts.
□ Qualifies for Small Business fee discounts
and fee waiver for first premarket application.

SBD12
□ Does not qualify.
U.S. Food and Drug Administration
Forms Comments
An agency may not conduct or sponsor, and a
10903 New Hampshire Avenue
person is not required to respond to, a
Building 66, Room 4613
collection of information unless it displays a
Silver Spring, MD 20993
currently valid Office of Management and
United States of America
Budget (OMB) control number.

Instructions — FY 2011 MDUFMA Foreign Small Business Qualification Certification

1

Contains Nonbinding Recommendations

Instructions for Completing Your
FY 2012 MDUFMA Foreign Small Business Qualification Certification
For a Business Headquartered Outside the United States
Form FDA 3602A
You should complete and submit an FY 2012 MDUFMA Foreign Small Business Qualification
Certification, Form FDA 3602A (for FY 2012), if you wish to be eligible for reduced or waived fees for
medical device submissions you make during FY 2012 (submissions received by FDA from October 1,
2011 through September 30, 2012). If you have any affiliates, you should also submit additional
supporting documentation —
•
•

a copy of the most recent Federal (U.S.) income tax return for each of your affiliates
headquartered in the United States, and
a copy of an FY 2012 MDUFMA Foreign Small Business Qualification Certification for each of
your foreign affiliates.

FDA will use these materials to decide whether you qualify as a small business within the meaning of
MDUFMA.
You should mail your FY 2012 MDUFMA Foreign Small Business Qualification Certification and all
supporting documentation to FDA at this address —
FY 2012 MDUFMA Small Business Qualification
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Avenue
Building 66, Room 4613
Silver Spring, MD 20993
United States of America
If you need assistance, please contact the Division of Small Manufacturers, International and Consumer
Assistance at 1-800-638-2041 or 1-301-796-7100.

Section I — Information about the Business Requesting Small Business Status
1. Name of business claiming MDUFMA Small Business status. You should provide the full

legal name of the business –
•

If the business is a corporation, limited liability company, partnership, or other legal entity,
provide the name used in its articles of incorporation, articles of organization, partnership

Instructions — FY 2011 MDUFMA Foreign Small Business Qualification Certification

1

Contains Nonbinding Recommendations
registration, or other similar instrument filed with the government under whose laws the business
was created.
•

If the business is a sole proprietorship owned entirely by one individual, provide the name used
when filing income taxes.

2. Taxpayer Identification Number. This is the identification number used by your National Taxing
Authority to uniquely identify your business.
3. Address where business is physically located. This is the address where the business is

physically located (the address you would give to a person who needed to travel directly to the business’s
primary establishment).
4. Name of person making this Certification. This is the person who is responsible for the accuracy

and completeness of the information provided in the Certification and who must sign the Certification
(see item 15). Only the head of your firm or your chief financial officer can make and sign the
Certification; see sections 738(d)(2)(B)(iii) and 738(e)(2)(B)(iii) of the FD&C Act.
5. Your telephone number. This is the telephone number where FDA can reach you if we have a

question concerning your FY 2012 MDUFMA Small Business Qualification Certification.
6. Your mailing address. This is the address to which you want FDA to send its decision letter

informing you that you are, or are not, a small business. If your mailing address is the same as item 3,
you can just check the box rather than repeating the information.
7. Your e-mail address. This is the e-mail address where FDA can reach you if we have a question

concerning your FY 2012 MDUFMA Small Business Qualification Certification.

Instructions — FY 2011 MDUFMA Foreign Small Business Qualification Certification

2

Contains Nonbinding Recommendations

Section II — Information about Your Affiliates
Section II of the form provides space for listing up to 10 affiliates; if you have more than 10 affiliates,
you may provide the additional information on one or more additional copies of Section II.
Lines 1 through 10 —
List each affiliate on a separate line. For each, you should
provide the following information —
a. Name of Affiliate. Provide the full legal name of the
affiliate –
•

•

If the affiliate is a corporation, limited liability
company, partnership, or other legal entity, you
should provide the name used in its articles of
incorporation, articles of organization, partnership
registration, or other similar instrument filed with
the Nation, State, or other government under whose
laws the firm was created.

What is an affiliate? This term is
defined by § 737(12) of the Federal
Food, Drug, and Cosmetic Act.
Affiliate means a business entity that
has a relationship with a second
business entity where, directly or
indirectly —
(a) one business entity
controls, or has the power to
control, the other business
entity; or
(b) a third party controls, or
has power to control, both of

the business entities.

If the affiliate is a sole proprietorship (that is, it is owned by an individual), you should
provide the name used when filing Foreign, Federal (U.S.), State, or other taxes.

b. Taxpayer ID Number. This number uniquely identifies each business —
•
•

If the affiliate is headquartered in the United States, you should provide the Employer
Identification Number (EIN) assigned to the affiliate by the U.S. Internal Revenue Service.
If the affiliate is headquartered outside the United States, you should provide the Taxpayer
Identification Number provided by the National Taxing Authority where the affiliate has its
headquarters.

c. Gross Receipts or Sales. For each affiliate headquartered in the United States, you should copy
this number from the most-recent Federal (U.S.) income tax return for the affiliate. For each affiliate
headquartered outside the United States, you should copy the information from item 3.b. of the
National Taxing Authority Certification for the affiliate.

Instructions — FY 2011 MDUFMA Foreign Small Business Qualification Certification

3

Contains Nonbinding Recommendations

Where do I find the gross receipts or
sales of an affiliate headquartered in
the United States? Your affiliate
reported its gross receipts or sales on its
most recent Federal income tax return.
IRS Form
Schedule C
(Form 1040)
Schedule C-EZ
(Form 1040)
Form 1065
Form 1065-B
Form 1120
Form 1120-F
Form 1120S
Form 990
Any other form

What is the most recent tax year of
an affiliate headquartered in the
United States? The most recent tax
year will be 2011, except —
•

See Line
Number
1
1
•
1a
1a
1a
Section II, 1a
1a
12
Please contact
FDA.

If you submit your FY 2012
MDUFMA Small Business
Qualification before April 15,
2012 and your affiliate has
not yet filed its return for
2011, you may use tax year
2010.
If you submit your FY 2012
MDUFMA Small Business
Qualification on or after
April 15, 2012 and your
affiliate has not yet filed your
2011 return because it
obtained an extension, you
may submit its most-recent
return filed prior to the
extension.

11. Total Gross Receipts and Sales of All Affiliates. This is the sum of the Gross Receipts or Sales
shown in column c. of lines 1 through 10.
12. Gross Receipts and Sales of the Business Making this Certification. This is the gross
receipts or sales of the business identified in Section I, item 1, as reported to your National Taxing
Authority.
13. Total Gross Receipts and Sales Used to Determine Qualification as a Small Business.
This is the sum of items 11 and 12. To qualify as a MDUFMA small business fee discounts, this sum
must be no more than $100 million. See sections 738(d)(2)(A) and 738(e)(2)(A) of the Act.
14. Have you attached a separate FY 2012 MDUFMA Foreign Small Business Qualification
Certification or a U.S. Federal income tax return for each of your affiliates? If you have any
affiliates, check the first box (“Yes”) and list them in Section II of the form. If you do not have any
affiliates, check the second box (“This business has no affiliates.”).

Instructions — FY 2011 MDUFMA Foreign Small Business Qualification Certification

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Contains Nonbinding Recommendations
15. Complete, sign, and date the following certification. In this certification, you should provide
the following information:
•

The name of the business that is claiming MDUFMA small business status. This should be
identical to your response to item 1.

•

Check one response to indicate whether the business has any affiliates —
o Check the first box if the business has no affiliates.
o Check the second box if the business has only the affiliates you listed in Section II of the
form.

•

The person identified in item 4 (“Name of person making this Certification”) must sign the
Certification.

•

Date the Certification (this is the date you signed the Certification).

Section III — National Taxing Authority Certification
After you have completed Sections I and II of your FY 2012 MDUFMA Foreign Small
Business Qualification Certification, you should submit it to your National Taxing
Authority.
What is my National Taxing Authority? Your National Taxing Authority is the government agency
that administers your national income tax. A list of National Taxing Authorities known to FDA is
provided in the Appendix that follows these instructions; this information is subject to change. If a
National Taxing Authority provides FDA with updated contact information, we will post it on our
Internet site at —
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA
Your National Taxing Authority is responsible for completing Section III — National Taxing Authority
Certification; you cannot complete this section yourself. You are responsible for identifying and
contacting your National Taxing Authority. Your National Taxing Authority should complete Section
III, and should then return your completed FY 2012 MDUFMA Foreign Small Business Qualification
Certification to you. You are responsible for sending your completed FY 2012 MDUFMA Foreign
Small Business Qualification Certification and all required supporting documentation to FDA.

Instructions — FY 2011 MDUFMA Foreign Small Business Qualification Certification

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Contains Nonbinding Recommendations

Appendix — National Taxing Authorities Known to FDA
This information is provided to help foreign applicants identify the National Taxing Authority that is
responsible for completing Section III — National Taxing Authority Certification of the FY 2012
MDUFMA Foreign Small Business Qualification Certification; see www.fda.gov/cdrh/mdufma for the
latest information known to FDA. This information is believed to be accurate as of August 2009, but is
subject to change. Each applicant is responsible for identifying and contacting the appropriate National
Taxing Authority.

Country
Australia
Austria
Belgium
Brazil
Canada
China
Czech
Republic
Finland
France

Germany
India
Ireland
Israel
Italy
Japan

National Taxing Authority
Australian Taxation Office (ATO)
http://www.ato.gov.au/
Ministry of Finance
https://www.bmf.gv.at/
Belgium Treasury, Ministry of Finance
http://www.minfin.fgov.be/portail2/index.htm
Ministry of Finance
http://www.receita.fazenda.gov.br/
Canada Revenue Agency
http://www.cra-arc.gc.ca/
State Administration of Taxation (SAT) Ministry of Finance
http://202.108.90.130/n6669073/index.html
Ministry of Finance of the Czech Republic
http://www.mfcr.cz/cps/rde/xchg/mfcr/hs.xsl/en.html
Finland Tax Administration
http://www.vero.fi/
Director General of Taxes (Corporate)
Treasury Department of France (Personal)
http://www.impots.gouv.fr/portal/dgi/home?pageId=home&sfid=00
Federal Ministry of Finances
http://www.bundesfinanzministerium.de/DE/BMF Startseite/node.html?
Ministry of Finance, Government of India
http://www.incometaxindia.gov.in/
Ireland Revenue – Irish Tax & Customs
http://www.revenue.ie/en/about/index.html
State of Israel, Ministry of Finance
http://ozar.mof.gov.il/mainpage_eng.asp
Ministry of Economy and Finances
http://www.finanze.it/export/finanze/index.htm
National Tax Agency
http://www.nta.go.jp/

Appendix — National Taxing Authorities Known to FDA

nnn=true

1

Contains Nonbinding Recommendations

Country

National Taxing Authority

The Hashemite Kingdom of Jordan
Income and Sales Tax Department, Ministry of Finance
http://www.nitc.gov.jo/En/
Ministry of Strategy and Finance (MOSF)
Korea
http://english.mofe.go.kr/
Luxembourg Luxembourg Ministry of Finance
http://www.mf.public.lu/
Inland Revenue Board of Malaysia
Malaysia
http://www.hasil.org.my/melayu/bm_index.asp
Republic of Mauritius
Mauritius
http://www.gov.mu/portal/site/treasurysite/menuitem.com
Secretary
of the Treasury and Public Credit
Mexico
http://www.shcp.gob.mx/Paginas/default.aspx
Tax and Customs Administration
The
http://www.belastingdienst.nl/
Netherlands
Inland Revenue Department
New
http://www.ird.govt.nz/
Zealand
Norwegian Ministry of Finance
Norway
http://www.regjeringen.no/en.html?id=4
Interregional Tax Inspectorate Department
Russian
http://www.nalog.ru/
Federation
Inland
Revenue Authority of Singapore (IRAS)
Singapore
http://www.iras.gov.sg/irashome/default.aspx
Agency of the Republic of Slovenia for Public Legal Records and Related Services
Slovenia
(AJPES) Ministry of Finance
http://www.gov.si/
South Africa South African Revenue Service (SARS)
http://www.sars.gov.za/
Spain Ministry of Economy
Spain
http://www.bircham.net/index.php?option=com_content&view=article&id=206&Ite
mid=117
Sweden Tax Board, Ministry of Finance
Sweden
http://www.skatteverket.se/english/inenglish.4.3a2a542410ab40a421c80006827.html
Taipei
National Tax Administration (TNTA) Ministry of Finance
Taiwan
http://www.ntat.gov.tw/
Republic of Turkey, Ministry of Finance
Turkey
http://www.maliye.gov.tr/
HM Revenue & Customs
United
http://www.hmrc.gov.uk/index.htm
Kingdom
Jordan

Appendix — National Taxing Authorities Known to FDA

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Contains Nonbinding Recommendations
Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average 2 hours,
including the time to review instructions, search existing data sources, gather the data needed,
and complete and review the information collection. Send comments regarding this burden
estimate or suggestions for reducing this burden to:
U.S. Food and Drug Administration
Forms Comments
10903 New Hampshire Avenue
Building 66, Room 4613
Silver Spring, MD 20993
United States of America
The guidance refers to approved collections of information under sections 738(d) and 738(e) of
the FD&C Act. The collections of information in Form FDA 3602 and Form FDA 3602A have
both been approved under OMB Control Number 0910-0508 (expires February 28, 2013).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number.