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Guidance for Industry, FDA,
and Foreign Governments:
FY 2010 Medical Device User Fee
Small Business Qualification
and Certification
Document issued August 3, 2009
As of September 1, 2009, this document supersedes
“Guidance for Industry, FDA, and Foreign Governments:
FY 2009 Medical Device User Fee Small Business
Qualification and Certification,” August 1, 2008.
OMB control numbers 0910‐0508 (expires December 31, 2010)
and 0910‐0613 (expires May 31, 2011).
See additional PRA statement at the end of this guidance.
For questions regarding this document contact
Mr. Yung Pak
Phone: 301‐796‐5856
e‐mail: yung.pak@fda.hhs.gov
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
Written comments and suggestions may be submitted at any time for Agency consideration to —
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane
Room 106 (HFA‐305)
Rockville, MD, 20852
Alternatively, electronic comments may be submitted to —
www.fda.gov/RegulatoryInformation/Dockets/Comments
Please identify your comments with the docket number listed in the notice of availability that publishes
in the Federal Register announcing the availability 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 —
Mr. Yung Pak
Phone: 301‐796‐5856
e‐mail: yung.pak@fda.hhs.gov
Additional Copies
Additional copies are available from the Internet at —
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA
You may also send an e‐mail request to dsmica@fda.hhs.gov to receive an electronic copy of the
guidance or send a fax request to 301‐847‐8149 to receive a hard copy. Please use the document
number (2010) to identify the guidance you are requesting.
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 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 —
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOmbudsman
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.
23 Total Gross Receipts and Sales Used to Determine Qualification as a Small Business $
(sum of lines 21 and 22)
Mail your completed FY 2010 Small Business Qualification Certification and (FDA Use Only)
copies of your latest Federal income tax return to the address below. You Review: □ Information verified
must also send a separate FY 2010 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
fee waiver for first premarket application
FY 2010 MDUFMA Small Business Qualification
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Avenue SBD10
Building 66, Room 4613
Silver Spring, MD 20993 □ Does not qualify
OMB Statement. The public reporting burden for this collection of information is estimated to U.S. Food and Drug Administration
An agency may not conduct or sponsor, and a
average 1 hour per response, including the time for reviewing instructions, searching existing data Forms Comments
person is not required to respond to, a
sources, gathering and maintaining the data needed, and completing and reviewing the collection 10903 New Hampshire Avenue
collection of information unless it displays a
of information. Send comments regarding this burden estimate or another aspect of this collection Building 66, Room 4613
currently valid Office of Management and
of information, including suggestions for reducing this burden to: Silver Spring, MD 20993
Budget (OMB) control number.
United States of America
Instructions for Completing Your
FY 2010 MDUFMA Small Business Qualification Certification
For a Business Headquartered in the United States
Form FDA 3602
You should complete and submit an FY 2010 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 2010 (submissions received by FDA from October 1, 2009
through September 30, 2010). 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 2010 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 2010 MDUFMA Small Business Qualification Certification, and copies of
the Federal income tax returns that support your Certification, to FDA at this address —
FY 2010 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 –
• 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
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.
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 2010 MDUFMA Foreign Small Business Qualification Certification or
a U.S. Federal income tax return for each of your affiliates?
Check (X) 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.
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 2010 Small Business (U.S. FDA Use Only)
Qualification Certification to FDA at the address below. Your Certification is not complete and will not
Review: □ Certification is complete.
be accepted unless Section III has been completed by your National Taxing Authority. If your business
□ Information not complete.
has any affiliates, you must also send a separate FY 2010 Small Business Qualification Certification or
U.S. Federal income tax return for each affiliate. Send all materials to — Decision: □ Qualifies for Small Business fee discounts.
□ Qualifies for Small Business fee discounts
FY 2010 MDUFMA Small Business Qualification
and fee waiver for first premarket application.
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Avenue
Building 66, Room 4613
SBD10
Silver Spring, MD 20993 United States of America
□ Does not qualify.
U.S. Food and Drug Administration
OMB Statement. The public reporting burden for this collection of information is estimated to Forms Comments An agency may not conduct or sponsor, and a
average 1 hour per response, including the time for reviewing instructions, searching existing data 10903 New Hampshire Avenue person is not required to respond to, a
sources, gathering and maintaining the data needed, and completing and reviewing the collection Building 66, Room 4613 collection of information unless it displays a
of information. Send comments regarding this burden estimate or another aspect of this Silver Spring, MD 20993 currently valid Office of Management and
collection of information, including suggestions for reducing this burden to: United States of America Budget (OMB) control number.
Instructions for Completing Your
FY 2010 MDUFMA Foreign Small Business Qualification Certification
For a Business Headquartered Outside the United States
Form FDA 3602A
You should complete and submit an FY 2010 MDUFMA Foreign Small Business Qualification
Certification, Form FDA 3602A (for FY 2010), if you wish to be eligible for reduced or waived fees for
medical device submissions you make during FY 2010 (submissions received by FDA from October 1,
2009 through September 30, 2010). 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 2010 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 2010 MDUFMA Foreign Small Business Qualification Certification and all
supporting documentation to FDA at this address —
FY 2010 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
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.