FY 2008 Guidance 0910-0613

FY 2008 Guidance 0910-0613.pdf

Medical Device User Fee Amendments of 2007; Foreign Small Business Certification Form FDA 3602 A

FY 2008 Guidance 0910-0613

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Guidance for Industry, FDA,
and Foreign Governments:

FY 2008 Medical Device User Fee
Small Business Qualification
and Certification
DRAFT — August 28, 2007

Document issued [Date]

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health

Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration to —
Dockets Management Branch (HFA-305)
Division of Management Systems and Policy
Office of Human Resources and Management Services
Food and Drug Administration
Room 1061
5630 Fishers Lane
Rockville, MD, 20852

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.
For questions regarding the use or interpretation of this guidance, contact —
Joseph V. Puleo
phone: (240) 276-3150, ext. 116
e-mail: [email protected]

Additional Copies
Additional copies are available from the Internet at: www.fda.gov/cdrh/mdufma/guidance.

This document is intended to provide guidance. It represents the Agency’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 the Food and Drug Administration (FDA) or the public. An
alternative approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

The Least Burdensome Approach
We believe we should consider the least burdensome approach in all areas of medical device
regulation. This guidance reflects our careful review of the relevant scientific and legal
requirements and what we believe is the least burdensome way for you to comply with those
requirements. However, if you believe that the information requested in the guidance is not
relevant to the decision-making process or that an alternative approach would be less
burdensome, please contact us so we can consider your point of view. You may send your
written comments to the contact person listed in the preface to this guidance or to the CDRH
Ombudsman. Comprehensive information on CDRH’s Ombudsman, including ways to contact
him, can be found on the Internet at —
www.fda.gov/cdrh/ombudsman

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 —
www.fda.gov/cdrh/mdufma
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.

Guidance for Industry, FDA, and Foreign Governments:

FY 2008 Medical Device User Fee
Small Business Qualification and Certification

Important Changes to the FY 2008 Guidance
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”) creates
additional types of fees and has led to several important changes in how you qualify as a
small business for FY 2008. The following considerations are particularly significant:
•

The guidance explains that there is no small business discount for the new
establishment registration fee. See section I of the guidance, p. 1. If this is the only
fee you expect to pay during FY 2008, do not submit an FY 2008 Small Business
Qualification Certification.

•

A foreign business may now qualify as a small business, even if the entity has not
submitted a Federal (U.S.) income tax return. See section III of the guidance, p. 7.

•

Guidance is provided for foreign governments, explaining how to prepare the new
“National Taxing Authority Certification” for a foreign business that is trying to
qualify as a MDUFMA small business. See section IV of the guidance, p. 10

•

The name of the guidance and all references to the Federal Food, Drug, and
Cosmetic Act (“FD&C Act”) have been updated to reflect changes made by the
2007 Amendments. Throughout the guidance, “MDUFMA” is used to refer to the
medical device user fee provisions of the FD&C Act, as amended through 2007.

Contents
I. Benefits of Qualifying as a Small Business.. . . . . . . . . . . . . . . . . . . . . . . . . . . 1
II. Guidance for U.S. Businesses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
III. Guidance for Foreign Businesses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
IV. Guidance for Foreign Governments — Preparation of a National
Taxing Authority Certification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
V. Frequently-asked Questions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Appendix — Forms and Instructions.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
• FY 2008 MDUFMA Small Business Qualification and Certification
• FY 2008 MDUFMA Foreign Small Business Qualification and Certification

Guidance for Industry, FDA, and Foreign Governments:

FY 2008 Medical Device User Fee
Small Business Qualification and Certification
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 —
N each of your medical device submissions that is subject to a user fee;
N 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.

•

You may obtain a one-time waiver of the fee for your (ever) first premarket
application. (PMA, BLA, PDP, 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.

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 2008, do not submit an FY 2008 Small
Business Qualification Certification.
What are the standard and small business fees for FY 2008? The fees for FY 2008 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 2008, you are eligible to pay a reduced fee for any
submissions or reporting you make during FY 2008.

FY 2008 MDUFMA Small Business Qualification and Certification

Medical Device Fees for FY 2008
Fees Relating to Medical Device Applications
Application Type

Standard Fee

Small Business

Premarket Application (PMA, BLA, PDP, premarket report)

$185,000

$46,250

Panel-track PMA supplement

$138,750

$34,688

BLA efficacy supplement

$185,000

$46,250

180-day PMA supplement

$27,750

$6,938

Real-time PMA supplement

$12,950

$3,238

510(k) premarket notification

$3,404

$1,702

30-day notice

$2,960

$1,480

513(g) request for classification information

$2,498

$1,249

Annual fee for periodic reporting on a class III device

$6,475

$1,619

Establishment Registration Fee — There is no reduced fee for a small business. If this
is the only fee you expect to pay during FY 2008, do not submit an FY 2008 Small
Business Qualification Certification.
Type of Fee
Establishment registration fee

Annual Fee
$1,706

Who can qualify as a small business under MDUFMA? Both domestic (U.S.) and foreign
businesses may qualify as a small business. For FY 2008, 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. 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).

FY 2008 MDUFMA Small Business Qualification and Certification

How can I obtain an FDA decision that I am a small business for FY 2008? The
qualification process depends on whether you are a domestic (U.S.) or foreign business:
•

•

If you are a domestic business headquartered in the United States, you will submit an
FY 2008 MDUFMA Small Business Qualification Certification and copies of your
most-recent Federal (U.S.) income tax returns directly to FDA. You will also submit
a Federal (U.S.) income tax return or an FY 2008 MDUFMA Foreign Small Business
Qualification Certification for each of your affiliates. See Section III, p. 4.
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 will determine your gross receipts or
sales in U.S. dollars and will provide you a National Taxing Authority Certification that
you will submit to FDA as part of your FY 2008 MDUFMA Foreign Small Business
Qualification Certification. You will also submit a Federal (U.S.) income tax return
or an FY 2008 MDUFMA Foreign Small Business Qualification Certification for each
of your affiliates. See Section IV, p. 12.

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. 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, the law requires you to count prior premarket applications made by your affiliates,
partners, or parent firms 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.

FY 2008 MDUFMA Small Business Qualification and Certification

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 2008 MDUFMA Small Business Qualification Certification, Form FDA
3602-US (for FY 2008), 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 2008 (submissions received by FDA from October 1, 2007
through September 30, 2008). 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 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(11) of the Federal Food, Drug, and
Cosmetic 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.
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 Federal Food, Drug, and Cosmetic 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.

FY 2008 MDUFMA Small Business Qualification and Certification

What is the most recent tax year? The most recent tax year will be 2007, except —
•
•

If you submit your FY 2008 MDUFMA Small Business Qualification before April 15,
2008 and you have not yet filed your return for 2007, you may use tax year 2006.
If you submit your FY 2008 MDUFMA Small Business Qualification after April 15,
2008 and you have not yet filed your 2007 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 Federal Food, Drug, and Cosmetic 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. 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 under MDUFMA. See sections 738(d)(2)(B) and
738(e)(2)(B) of the Federal Food, Drug, and Cosmetic Act. If you have a foreign affiliate, you
must submit a separate FY 2008 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 2008 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 —
www.fda.gov/cdrh/mdufma/guidance/2008.pdf
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.

FY 2008 MDUFMA Small Business Qualification and Certification

Where do I send my completed FY 2008 MDUFMA Small Business Qualification
Certification and supporting materials?
Send your completed Certification and all supporting documentation to:
FY 2008 MDUFMA Small Business Qualification (HFZ-222)
Division of Small Manufacturers, International, and Consumer Assistance
1350 Piccard Dr.
Rockville, MD 20850

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

FY 2008 MDUFMA Small Business Qualification and 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 believe you qualify as a small business and want to pay reduced or waived fees, you will
complete Sections I and II of an FY 2008 MDUFMA Foreign Small Business Qualification
Certification and you will then submit your Certification and supporting evidence of
qualification to your National Taxing Authority (the equivalent of the United States Internal
Revenue Service). Your National Taxing Authority will complete Section III, National Taxing
Authority Certification, and will return your completed FY 2008 MDUFMA Foreign Small
Business Qualification Certification to you. You will then send your Certification and
supporting evidence of qualification 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 2008 (submissions received by FDA from October 1, 2007
through September 30, 2008). 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 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(11) of the Federal Food, Drug, and
Cosmetic 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 www.fda.gov/cdrh/mdufma. If
we have not posted contact information for your National Taxing Authority, it is your
responsibility to identify the appropriate point of contact.

FY 2008 MDUFMA Small Business Qualification and Certification

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 2008 Foreign Small Business
Qualification Certification, 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 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 2008 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 —
www.fda.gov/cdrh/mdufma/guidance/2008.pdf
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 it to your National Taxing Authority
with any additional information or materials required by the National Taxing Authority.
Your National Taxing Authority will complete Section III, National Taxing Authority
Certification, and you will then send your completed FY 2008 MDUFMA Foreign Small
Business Qualification Certification and supporting evidence to FDA.

FY 2008 MDUFMA Small Business Qualification and Certification

Where do I send my completed FY 2008 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, send your FY 2008 MDUFMA Foreign Small Business Qualification
Certification and all supporting documentation to:
FY 2008 MDUFMA Foreign Small Business Qualification (HFZ-222)
Division of Small Manufacturers, International, and Consumer Assistance
1350 Piccard Dr.
Rockville, MD 20850
United States of America

FY 2008 MDUFMA Small Business Qualification and Certification

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

The FY 2008 MDUFMA Foreign Small Business Qualification Certification, Form FDA
3602-Foreign (for FY 2008), 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 Federal Food, Drug, and
Cosmetic 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.

FY 2008 MDUFMA Small Business Qualification and Certification

What information must the business submit to the National Taxing Authority?
The business will provide an FY 2008 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?
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
Federal Food, Drug, and Cosmetic Act require the National Taxing Authority Certification
to bear the official seal of the National Taxing Authority.

FY 2008 MDUFMA Small Business Qualification and Certification

V. Frequently-asked Questions
What is the purpose of a Small Business Decision number? You will use your Small Business
Decision number to demonstrate that you have qualified as a small business for FY 2008. For
example, whenever you submit a Medical Device User Fee Cover Sheet (Form FDA 3601),
you will 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 must 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 must 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, do not
submit your application until you obtain your Small Business Decision number from FDA.
When will my status as a small business expire? Your status as a small business will expire
September 30, 2008.
Will I need to requalify as a small business for FY 2009 and future years? Yes. You will
have to 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.”

FY 2008 MDUFMA Small Business Qualification and Certification

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 appear 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 240-276-3150.

FY 2008 MDUFMA Small Business Qualification and Certification

Appendix — Forms and Instructions
This appendix provides a copy of —
•

•

FY 2008 MDUFMA Small Business Qualification Certification, Form FDA 3602-US
(for FY 2008). You should use this form if your business is headquartered in the
United States. Instructions are provided immediately after the form.
FY 2008 MDUFMA Foreign Small Business Qualification Certification, Form FDA
3602-Foreign (for FY 2008). You should use this form if your business is
headquartered outside the United States. Instructions are provided immediately after
the form.

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. The PDF version of this guidance is available on the
Internet at —
www.fda.gov/cdrh/mdufma/guidance/2008.pdf
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.

FY 2008 MDUFMA Small Business Qualification and Certification

Form Approved: January 9, 2004

FY 2008 MDUFMA Small Business
Qualification Certification

Expiration Date: December 31, 2010
OMB Statement: See last page.

For a Business Headquartered in the United States

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:

G Check (T) if same as item 3.

Telephone Number

7. Your e-mail address:

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

9. Have you listed all of the business’s affiliates in Section II of this form?
Check (T) one response:

G Yes

G This business 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:)
G 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.
G has only the affiliates listed in Section II of this form, 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 of 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-US (for FY 2008)

OMB Control Number 0910-0508

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

b. Taxpayer ID Number

c. Gross Receipts or Sales

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

Gross Receipts and Sales of the Business M aking this Certification

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

Mail your completed FY 2008 Small Business Qualification Certification
and copies of your latest Federal income tax return to the address below.
You must also send a separate FY 2008 Small Business Qualification
Certification or U.S. Federal income tax return or for of each of your
affiliates. Send all materials to —
FY 2008 Small Business Qualification (HFZ-222)
Division of Small Manufacturers, International, and Consumer Assistance
1350 Piccard Dr.
Rockville, MD 20850

(FDA U se O nly)

Review:

G Information verified
G Information not verified

Decision:

G Qualifies for Small Business fee discounts
G Qualifies for Small Business fee discounts and
fee waiver for first premarket application
SBD08
G Does not qualify

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, HFZ-20
2098 Gaither Road
Rockville, MD 20850
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.

Instructions for Completing Your
FY 2008 MDUFMA Small Business Qualification Certification
For a Business Headquartered in the United States
Form FDA 3602-US
You must complete and submit an FY 2008 MDUFA Small Business Qualification
Certification (Form FDA 3602) in order to be eligible for reduced or waived fees for medical
device submissions you make during FY 2008 (submissions received by FDA from October 1,
2007 through September 30, 2008). You must also submit —
•
•

a copy of your most recent Federal (U.S.) income tax return, and
if you have any affiliates —
N
a copy of the most recent Federal income tax return of each of your domestic
(U.S.) affiliates, and
N
a copy of an FY 2008 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.
Mail your FY 2008 MDUFMA Small Business Qualification Certification, and copies of the
Federal income tax returns that support your Certification, to FDA at this address —
FY 2008 MDUFMA Small Business Qualification (HFZ-222)
Division of Small Manufacturers, International, and Consumer Assistance
1350 Piccard Dr.
Rockville, MD 20850

If you need assistance, please contact the Division of Small Manufacturers, International and
Consumer Assistance at 800-638-2041 or 240-276-3150.

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

•

If the business is a corporation, limited liability company, partnership, or other legal
entity, 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, the name used
when filing Federal, State, or other taxes.

Instructions — FY 2008 MDUFMA Small Business Qualification Certification (U.S.)

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.
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).
3.

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).
4.

Your telephone number. This is the telephone number where FDA can reach you if we
have a question concerning your FY 2008 MDUFMA Small Business Qualification
Certification.
5.

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.
6.

Your e-mail address. This is the e-mail address where FDA can reach you if we have a
question concerning your FY 2008 MDUFMA Small Business Qualification Certification.
7.

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 2008 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.”).
10. Complete, sign, and date the following certification. In this certification, you must
provide the following information:
•

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

•

Check one response to indicate whether the business has any affiliates —
N
N

Check the first box if the business has no affiliates.
Check the second box if the business has only the affiliates you listed in
Section II of the form.

Instructions — FY 2008 MDUFMA Small Business Qualification Certification (U.S.)

•

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 —
N

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

See Line Number

Schedule C
(Form 1040)

Schedule C-EZ
(Form 1040)

Form 1065

Form 1065-B

Form 1120
Form 1120-F

1a
Section II, 1a

Form 1120S

Form 990

Any other form

Please contact FDA.

What is the most recent tax year? The
most recent tax year will be 2007,
except —
• If you submit your FY 2008
MDUFMA Small Business
Qualification before April 16, 2008
and you have not yet filed your
return for 2008, you may use tax
year 2006.
• If you submit your FY 2008
MDUFMA Small Business
Qualification after April 16, 2008
and have not yet filed your 2007
return because you obtained an
extension, you may submit your
most-recent return filed prior to
the extension.

Instructions — FY 2008 MDUFMA Small Business Qualification Certification (U.S.)

Check the second box if the business
and all of its affiliates together
reported “gross receipts or sales” of no
more than $30 million on their most
recent Federal income tax returns.
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(11) of the Federal
Food, D rug, and C osm etic 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.

•

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 II — Information about Your Affiliates
You must provide certain information about each of 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, 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, 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), provide the
name used when filing Federal, State, or other taxes.

Instructions — FY 2008 MDUFMA Small Business Qualification Certification (U.S.)

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

•

If the affiliate is headquartered in the United States, 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, 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, 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, copy the information from item 3.b. of the
National Taxing Authority Certification for the affiliate.
Line 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.
Line 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.
Line 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.

Instructions — FY 2008 MDUFMA Small Business Qualification Certification (U.S.)

Form Approved:

FY 2008 MDUFMA Foreign Small Business
Qualification Certification

Expiration Date:

For a Business Headquartered Outside the United States

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 Num ber:

3. Address where business is physically located:

4. Name of person making this Certification:

5. Your telephone number:

Check (T) one response: G Head of Firm

G Chief Financial Officer
G Check (T) if same as item 3.

6. Your mailing address:

7. Your e-mail address:

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

b. Taxpayer ID Number

c. Gross Receipts or Sales

10.

11.

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

12.

Gross Receipts and Sales of the Business M aking 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 2008 M DUFM A Foreign Small Business Qualification Certification or
a U.S. Federal income tax return for each of your affiliates?
Check (T) one response:

G Yes

This business has no affiliates.

15. Complete, sign, and date the following certification:
I certify that
N am e of business (m ust be identical to response to item 1)

(Check one response:)
G 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.
G has only the affiliates listed in item 7, 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 3)

Form FDA 3602-Foreign (for FY 2008)

OMB Control Number 0910-0508

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 (T) one response
G The business requesting small business status. (All of Section I must be completed.)
G 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 for
the most recent tax year:
Currency Unit

Amount Reported

a. Local currency:
b. U.S. currency:

4. Does the National Taxing Authority
know of any affiliate(s) of the business
requesting small business status, other
than those listed in Section II?
Check (T) one response:

U.S. Dollars

G No (or not applicable).
G Yes. An explanation is attached.

c. Exchange rate (per U.S. Dollar):
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 O fficial Seal of N ational 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 5)

Date of this Certification:
The business seeking sm all business status should m ail its com pleted FY 2008 Sm all
Business Q ualification C ertification to FDA at the address below . Your
C ertification is not com plete and w ill not be accepted unless Section III has been
com pleted by your N ational Taxing Authority. If your business has any affiliates, you
m ust also send a separate FY 2008 Sm all Business Q ualification C ertification or U .S.
Federal incom e tax return for each affiliate. Send all m aterials to —
FY 2008 Sm all Business Q ualification (H FZ-222)
D ivision of Sm all M anufacturers, International, and C onsum er A ssistance
U .S. Food and D rug Adm inistration
1350 Piccard D r.
Rockville, M D 20850
U nited States of A m erica
O M B Statem ent. T he pub lic reporting burden for this collection of inform ation is estim ated
to average 1 hour per response, including the tim e for reviewing instructions, searching existing
data sources, gathering and m aintaining the data needed, and com pleting and reviewing the
collection of inform ation. Send com m ents regarding this burden estim ate or another aspect of
this collection of inform ation, including suggestions for reducing this burden to:

(U .S. FDA U se O nly)
Review:

G C ertification is com plete.
G Inform ation not com plete.

D ecision:

G Q ualifies for Sm all Business fee discounts.
G Q ualifies for Sm all Business fee discounts
and fee w aiver for first prem arket application.

SBD 08
G D oes not qualify.

U .S. Food and D rug Adm inistration
Form s C om m ents, H FZ-20
2098 G aither Road
Rockville, M D 20850
U nited States of A m erica

A n agency m ay not conduct or sponsor, and
a person is not required to respond to, a
collection of inform ation unless it displays a
currently valid O ffice of M anagem ent and
Budget (O M B) control num ber.

Instructions for Completing Your
FY 2008 MDUFMA Foreign Small Business Qualification Certification
For a Business Headquartered Outside the United States
Form FDA 3602-Foreign
You must complete and submit an FY 2008 MDUFA Foreign Small Business Qualification
Certification, Form FDA 3602-Foreign (for FY 2008), in order to be eligible for reduced or
waived fees for medical device submissions you make during FY 2008 (submissions
received by FDA from October 1, 2007 through September 30, 2008). If you have any
affiliates, you must 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 2008 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.
Mail your FY 2008 MDUFMA Foreign Small Business Qualification Certification and all
supporting documentation to FDA at this address —
FY 2008 MDUFMA Foreign Small Business Qualification (HFZ-222)
Division of Small Manufacturers, International, and Consumer Assistance
1350 Piccard Dr.
Rockville, MD 20850

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 1-240-276-3150.

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

•

If the business is a corporation, limited liability company, partnership, or other legal
entity, the name used in its articles of incorporation, articles of organization,
partnership 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, the name
used when filing income taxes.

Instructions — FY 2008 MDUFMA Foreign Small Business Qualification Certification

2. Taxpayer Identification Number. This is the identification number used by your
National Taxing Authority to uniquely identify your business.
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).
3.

Your telephone number. This is the telephone number where FDA can reach you if we
have a question concerning your FY 2008 MDUFMA Small Business Qualification
Certification.
5.

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.
6.

Your e-mail address. This is the e-mail address where FDA can reach you if we have a
question concerning your FY 2008 MDUFMA Small Business Qualification Certification.
7.

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 2008
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.”).
10. Complete, sign, and date the following certification. In this certification, you must
provide the following information:
•

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

•

Check one response to indicate whether the business has any affiliates —
N
N

Check the first box if the business has no affiliates.
Check the second box if the business has only the affiliates you listed in
Section II of the form.

Instructions — FY 2008 MDUFMA Foreign Small Business Qualification Certification

•

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 —
N

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

1a
Section II, 1a

Form 1120S

Form 990

Any other form

See Line Number

Please contact FDA.

Check the second box if the business
and all of its affiliates together
reported “gross receipts or sales” of
no more than $30 million on their
most recent Federal income tax
returns. 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.

•

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).

Instructions — FY 2008 MDUFMA Foreign Small Business Qualification Certification

Section II — Information about Your Affiliates
You must provide certain information about each of 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, provide the following information —
a. Name of Affiliate. Provide the full legal name of the affiliate –
•

•

If the affiliate is a sole proprietorship (that is, it is owned by an individual), provide
the name used when filing national income taxes.

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

•

c. Gross Receipts or Sales. For each affiliate headquartered in the United States, 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, copy the information
from item 3.b. of the National Taxing Authority Certification for the affiliate.
Line 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.
Line 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.

Instructions — FY 2008 MDUFMA Foreign Small Business Qualification Certification

Line 13 — Total Gross Receipts and Sales Used to Determine Qualification as a Small
Business. This is the sum of lines 11 and 12. To qualify as a MDUFMA small business fee
discounts, this sum must be no more than $100 million.

Section III — National Taxing Authority Certification
i

After you have completed Sections I and II of your FY 2008 MDUFMA Foreign
Small Business Qualification Certification, you must submit it to your National
Taxing Authority.

Your National Taxing Authority will
What is my National Taxing Authority?
complete Section III — National Taxing
Your National Taxing Authority is the
Authority Certification; you cannot
government agency that administers your
complete this section yourself. You are
national income tax. If a National Taxing
responsible for identifying and contacting
Authority provides FDA will contact
your National Taxing Authority. Your
information, we will post it on our Internet
National Taxing Authority will complete
site at www.fda.gov/cdrh/mdufma.
Section III, and will then return your
completed FY 2008 MDUFMA Foreign
Small Business Qualification Certification to you. You are responsible for sending your
completed FY 2008 MDUFMA Foreign Small Business Qualification Certification and all
required supporting documentation to FDA.

Instructions — FY 2008 MDUFMA Foreign Small Business Qualification Certification

File Type	application/pdf
File Modified	2008-04-11
File Created	2007-08-28