Contains Nonbinding Recommendations
Medical Device User Fee Small 
Business Qualification
and Certification
Guidance for Industry, Food and Drug 
Administration Staff and Foreign 
Governments
Document issued on August 1, 2018.
This document supersedes FY 2018 Medical Device User Fee Small Business 
Qualification and Certification; Guidance for Industry, Food and Drug 
Administration Staff and Foreign Governments dated August 29, 2017.
For questions about this document regarding CDRH-regulated devices, contact CDRHs Division 
of Industry and Consumer Education at 800-638-2041 or DICE@fda.hhs.gov. 
For questions about this document regarding CBER-regulated devices, contact the Office of 
Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.
The OMB control number for this information collection is 0910-0508 (expires May 31, 2022). 
     U.S. Department of Health and Human 
Services 
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
1 Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.  
Identify all comments with the docket number FDA-2018-D-1873. Comments may not be acted 
upon by the Agency until the document is next revised or updated.
Additional Copies
CDRH
Additional copies are available from the Internet.  You may also send an e-mail request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance.  Please use the document number 
GUD18007 to identify the guidance you are requesting.
CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 
Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-
8010, by email, ocod@fda.hhs.gov or from the Internet at https://www.fda.gov/vaccines-blood-
biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances 
2 Contains Nonbinding Recommendations
Table of Contents
I.  Introduction .............................................................................................................................. 4
II.  Overview .................................................................................................................................. 5
A. Eligibility .......................................................................................................................................................... 5
B.  U.S. Businesses ................................................................................................................................................ 6
C.  Foreign Businesses ........................................................................................................................................... 6
D.  National Taxing Authority ............................................................................................................................... 7
E.  Important Note for Submitters of Pre-FY2019 Small Business Certification Requests ................................... 7
III.  Small Business Fees: MDUFA User Fee Schedule, Benefits, and First Premarket 
Application Fee Waiver .............................................................................................................. 8
A.  MDUFA User Fee Schedule ............................................................................................................................ 8
B.  Benefits of Qualifying as a Small Business ..................................................................................................... 8
C.  First Premarket Application/Report Fee Waiver .......................................................................................... 8
IV.  Guidance for U.S. Businesses ............................................................................................... 9
V.  Guidance for Foreign Businesses ......................................................................................... 12
VI.  Guidance for Foreign Governments  How to Prepare a National Taxing Authority 
Certification ................................................................................................................................. 14
VII.  Frequently Asked Questions ............................................................................................. 16
VIII.  Appendix Instructions for Completion of Form FDA 3602 and 3602A .................. 18
Appendix 1:  General Instructions for Completion of Forms .............................................................................. 20
Appendix 2:  Instructions for Completing Form FDA 3602 (MDUFA Small Business Certification Request, for a 
Business Headquartered in the United States) ..................................................................................................... 21
Appendix 3:  Instructions for Completing Form FDA 3602A (MDUFA Foreign Small Business Certification 
Request, for a Business Headquartered Outside the United States) ..................................................................... 26
IX. Paperwork Reduction Act of 1995 ...................................................................................... 31
3 Contains Nonbinding Recommendations
Medical Device User Fee
Small Business Qualification
and Certification
Guidance for Industry, Food and 
Drug Administration Staff, and 
Foreign Governments
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic.  It does not establish any rights for any person and is not binding 
on FDA or the public.  You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff or Office responsible for this guidance as listed on the title page. 
I.  Introduction
The Medical Device User Fee Amendments (MDUFA) require the payment of a user fee for 
most types of medical device applications.  A business that is qualified and certified as a 
small business is eligible for a substantial reduction in most of these user fees.  Application 
types eligible for reduced small business fee are:  Premarket Notification (510(k)), De Novo 
request, Premarket Applications (Premarket Approval Application [PMA], Biologics License 
Application [BLA], Product Development Protocol [PDP]), Premarket Report (PMR), 
PMA/BLA Supplements and PMA Annual Reports, and 513(g) request for classification 
information.  See the full list of eligible application types at the MDUFA User Fees website.1
This guidance describes the process for how a business may request qualification and 
certification as a small business.
For purposes of this guidance, note, there should be a National Taxing Authority within the 
Foreign Government who will be responsible for completion of the appropriate sections of 
the Form FDA 3602A.  In this guidance, we will refer to Foreign Government and 
National Taxing Authority interchangeably.  
The contents of this document do not have the force and effect of law and are not meant to 
bind the public in any way, unless specifically incorporated into a contract. This document is 
intended only to provide clarity to the public regarding existing requirements under the law. 
1 https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa 
4 Contains Nonbinding Recommendations
FDA guidance documents, including this guidance, should be viewed only as 
recommendations, unless specific regulatory or statutory requirements are cited. The use of 
the word should in Agency guidance means that something is suggested or recommended, 
but not required. 
II.  Overview 
Information about the process based on your role is described in the following sections of 
this guidance:
for a U.S. Business:
 
 see Section II(B) and Section IV
 use Form FDA 3602 MDUFA Small Business Certification Request, for a Business 
Headquartered in the United States
  if you have foreign affiliates, use Form FDA 3602A, MDUFA Foreign Small 
Business  Certification Request, for a Business Headquartered Outside the United 
States for each foreign affiliate  
for a Foreign Business:
 
 see Section II(C) and Section V
 use Form FDA 3602A MDUFA Foreign Small Business Certification Request, for a 
Business Headquartered Outside the United States
for a National Taxing Authority:
 
 see Section II(D) and Section VI
 work with your Foreign Business/Affiliate to complete Form FDA 3602A MDUFA 
Foreign Small Business Certification Request, for a Business Headquartered Outside 
the United States
As you review this guidance, please follow the instructions and complete the form(s) 
appropriate for your business.
For additional information about medical device user fees, see FDAs Medical Device User 
Fees web site at:  
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-
amendments-mdufa 
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.
A. Eligibility 
To be eligible for a reduced small business fee, you must qualify as a small business.  This 
is defined as having 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.2  More information about the general 
2 See Sections 738(d)(2)(A) and 738(e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
5 Contains Nonbinding Recommendations
applicability may be found in Section III (Small Business Fees:  Fee Schedule, Benefits and 
First Premarket Application Fee Waiver) and Section VII (Frequently-Asked Questions) 
of this guidance.
The establishment registration fee is not eligible for a reduced small business fee.  If the only 
user fee you expect to pay in the Fiscal Year (FY) is the establishment registration fee (i.e., 
you do not plan to submit an application requiring a user fee), you receive no benefit from 
submitting a Small Business Certification Request.  Please do not submit such requests.
A Small Business Certification is granted for a FY and expires at the end of that FY. A FY 
runs from October 1 through September 30 of the following year.  A sponsor who wishes to 
apply any applicable reduction in user fee for a submission must apply and be granted the 
Small Business Certification for each FY in which they plan to submit a medical device 
application that requires a user fee. 3  
The FDA accepts Small Business Certification Request beginning August 1 prior to next FY 
starting on October 1.  For example, requests for FY 2019 status (which runs from October 1, 
2018 through September 30, 2019) will be accepted from August 1, 2018 through September 
30, 2019.  Small Business Certification Request for the next FY received before August 1 
will not be accepted.  Please plan your request strategy accordingly.
B.  U.S. Businesses
If your business is headquartered in the United States, you should follow the guidance in 
Section IV (Guidance for U.S. Businesses).  To qualify as a small business, please complete 
Form FDA 3602 (MDUFA Small Business Certification Request, for a Business 
Headquartered in the United States), and submit the completed form to FDA.  Appendix 1 of 
this guidance contains instructions for accessing Form FDA 3602 and Appendix  2 of this 
guidance contains instructions for how to complete the Form FDA 3602.
If you have any foreign affiliates, please complete Form FDA 3602A for each foreign 
affiliate (see Appendix 3 for instructions for completing Form FDA 3602A).
C.  Foreign Businesses
If your business is a foreign business headquartered outside the United States and does not 
file a Federal (U.S.) income tax return, you should follow the guidance in Section V 
(Guidance for Foreign Businesses). To qualify as a small business, please follow these 
sequential steps:
1.  Reference Appendix 1 of this guidance for instructions for accessing Form FDA 3602A.
3 See Section 738(a)(2)(C) of the FD&C Act.
6 Contains Nonbinding Recommendations
2.  Reference Appendix 3 of this guidance for instructions on how to complete Form FDA 
3602A (MDUFA Foreign Small Business Certification Request, for a Business 
Headquartered Outside the United States).  
3.  Complete Sections I and II of Form FDA 3602A. 
4.  Submit Form FDA 3602A to your National Taxing Authority (the equivalent of the U.S. 
Internal Revenue Service), who then completes Section III of that form (i.e., National 
Taxing Authority Certification). 
5.  The National Taxing Authority should return the completed Form FDA 3602A to you. 
6.  Submit the completed Form FDA 3602A, with Sections I, II, and III fully completed, to 
FDA for review.  In addition, if your business has any foreign affiliates, you must send a 
separate certified Section III of Form FDA 3602A for each foreign affiliate.  If your 
business has any U.S. affiliates, you must send a Federal U.S. income tax return for each 
U.S. affiliate.
We recommend that you review Section VI (Guidance for Foreign Governments - How to 
Prepare a National Taxing Authority Certification) to understand the responsibility of your 
National Taxing Authority and, specifically, Section III of the Form FDA 3602A.  
D.  National Taxing Authority
If you are a National Taxing Authority, you should review Section VI (Guidance for Foreign 
Governments  How to Prepare a National Taxing Authority Certification) for instructions on 
your responsibilities.  Complete Section III for the Form FDA 3602A (National Taxing 
Authority Certification) submitted to you by a business headquartered in your nation and 
return the completed form back to the business that sent you the form.
E.  Important Note for Submitters of Pre-FY2019 Small Business 
Certification Requests
The process and principles described in this guidance are substantially similar to the FY 2018 
guidance.  Please be advised that the FDA continues to make quality improvements in the 
program, in areas such as administrative completeness and consistency of documentation.  
These updates assist the applicant in developing and submitting the Small Business 
Certification Request and the FDA in reviewing the request in a consistent, timely manner.  
As a result, it is important for current applicants to understand and follow the instructions 
described in this guidance document.  
Note:  The FDA Forms 3602 and 3602A are not printed for a specific FY.  Instead, 
businesses should indicate the FY for which the Small Business Certification Request is 
prepared in the upper right section of the header of the form. 
7 Contains Nonbinding Recommendations
III.  Small Business Fees: MDUFA User Fee Schedule, 
Benefits, and First Premarket Application Fee Waiver
This section identifies the MDUFA User Fee schedule, explains the benefits of qualifying as 
a small business and defines the first premarket application/report fee waiver.
A.  MDUFA User Fee Schedule
The standard MDUFA User Fee must be paid for the identified applications in order for FDA 
to begin its review, unless the applicant is eligible for a waiver or exemption. The current 
user fees are shown at the FDA MDUFA User Fees4 website and are set by law.5  If you 
qualify as a small business, you are eligible to pay a reduced fee for any application types 
listed at the FDA MDUFA User Fees Website, from the date of FDAs determination of your 
small business status through the end of that FY (i.e., September 30).
B.  Benefits of Qualifying as a Small Business
If you qualify as a small business, you will pay a lower user fee than the standard fee for 
applicable submissions [i.e., PMA, PDP, PMA and PDP Supplements (Panel-Track, 180-day, 
Real-Time and 30-day Notice), Modular PMA, BLA, BLA Efficacy Supplement, 510(k) 
(Traditional, Abbreviated, and Special), PMR, PMA Annual Reports, 513(g) and De Novo 
request]. 
C.  First Premarket Application/Report Fee Waiver
If the FDA determines that you are eligible for a first premarket application/report fee 
waiver, this means that you will be eligible to waive the fee for your first premarket 
application/report (i.e., PMA, including Modular PMA, BLA, PDP,or PMR).  This fee 
waiver may only be applied once.  The first premarket application/report is defined as the 
first PMA (including Modular PMA), BLA, PDP, or PMR received by FDA from a business 
entity or any of its affiliates.  If a second business entity (or any of its affiliates) acquires 
another business entity that has previously submitted a premarket application/report, then the 
second business entity is not eligible for a "first premarket application/report" waiver.
To qualify for the first premarket application/report fee waiver, you must meet both
criteria:
1. You must qualify as a small business with gross receipts or sales of no more than 
$30million, including the gross receipts or sales of all of your affiliates6.
Note:  This means that some businesses may qualify as a small business because their 
gross receipts or sales are less than $100 million but would not qualify for the first 
premarket application/report fee waiver if their gross receipts or sales are more than 
4 See the FDA MDUFA User Fees Website located at https://www.fda.gov/industry/fda-user-fee-programs/medical-
device-user-fee-amendments-mdufa 
5 See Sections 738(b) and 738(d) of the FD&C Act.
6 See Section 738(d)(1) of the FD&C Act.
8 Contains Nonbinding Recommendations
$30 million.
2.  FDA must determine that this is your first premarket application/report (i.e., PMA, 
including Modular PMA, BLA, PDP, or PMR).  Specifically, if you or any affiliate 
previously submitted a premarket application/report, then your next application does not 
qualify for the first premarket application/report fee waiver, and you must pay the fee 
that would otherwise apply.
Examples of situations that do not qualify for first premarket application/report":
A.  Business A has an approved PMA and is acquired by Business B.  Business B has 
not submitted a PMA, BLA, PDP or a Modular PMA to FDA.  Because Business A 
has submitted a PMA, Business B is not eligible for the first premarket 
application/report fee waiver. 
B.  A business with Name A has submitted a BLA and then changes its name to 
Name B. Under Name B, the business submits a Modular PMA.  This is considered 
the same Business.  The business is not eligible for the first premarket 
application/report fee waiver.
C.  A business submits a PMA that is not approved and then submits a Modular PMA 
for a different product.  The business is not eligible for the first premarket 
application/report fee waiver because it has already submitted a premarket application 
regardless of whether it was approved.
IV.  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 V (Guidance for Foreign 
Businesses).
If you believe you qualify as a small business and want to pay reduced fees or have fees 
waived  (for your first premarket application/report), you should submit the following 
documents to the FDA:
  a completed Form FDA 3602 (MDUFA Small Business Certification Request, for a 
Business Headquartered in the United States)  
o  include your Organization ID Number (Org ID) in box 2a of Form FDA 3602.  
Org ID is a system-generated number assigned to a new organization during the 
User Fee account creation process that uniquely identifies your business in the 
FDA User Fee System.7 Your Org ID is separate and distinct from any other 
number that may be associated with your company. See Section VII (Frequently-
Asked Questions) of this guidance for instructions on obtaining your Org ID;
7 Available at https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp?legalsel=2&ref.  
9 Contains Nonbinding Recommendations
  a complete, signed copy of your original Federal (U.S.) income tax return for the most 
recent tax year;
  a separate Federal (U.S.) income tax return for each U.S. affiliate; and
  certified Section III of Form FDA 3602A for each foreign affiliate. 
FDA will review your Form FDA 3602 and supporting materials within 60 calendar days of 
receipt.  Upon completion of our review, we will send you a letter that indicates whether or 
not your business has been qualified under MDUFA as a small business.  A qualified small 
business is then eligible for a reduced or waived fee for submissions made during the FY.  If 
your business is qualified as a small business, FDAs decision letter will assign you a Small 
Business Decision number.  You should provide this number to FDA each time you want to 
receive a small business fee discount for any of your eligible applications or, if you qualify, 
when you want to obtain a fee waiver for your first premarket application/report.
What is an affiliate?
The term affiliate is defined in Section 737(12) of the FD&C Act.  An affiliate means a 
business entity that has a relationship with a second business entity whether, 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 your affiliates with your own gross 
receipts or sales when you prepare your Form FDA 3602 (MDUFA Small Business 
Certification Request, for a Business Headquartered in the United States).   
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 (U.S.) income tax returns (and returns of all affiliates).  A 
consequence of this requirement is that you cannot qualify as a small business under 
MDUFA if you have not submitted a Federal (U.S.) income tax return.  FDA cannot accept a 
foreign tax return or state tax return in place of a Federal (U.S.) income tax return.
10 Contains Nonbinding Recommendations
What is an acceptable copy of Federal (U.S.) income tax returns?
An acceptable copy of Federal (U.S.) income tax returns is an identical signed copy of the 
entire original Federal (U.S.) income tax returns submitted to the United States Internal 
Revenue Service (IRS).  Please do not include your state tax return only the Federal (U.S) 
income tax return is needed.
The copy of the Federal (U.S.) income tax return must include the signature and the date of 
the signature of an officer, partner, or member of the company.  Alternatively, you may 
submit a copy of the e-file form submitted to the IRS, if your documentation includes a dated 
signature of an officer, partner or member.
What is the most recent tax year?
You should submit your most recent tax return.  If you submit your Small Business 
Certification Request prior to the current years due date for your taxes, you may submit your 
previous years tax return.
If you obtained an extension to file your taxes, then you may use your most recent return 
filed prior to the extension.  In this scenario, you should also include your IRS Form 7004: 
Application for Automatic Extension of Time To File Certain Business Income Tax, 
Information, and Other Returns in your Small Business Certification Request.
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 (U.S.) 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. In 
addition, include a signed copy of your Form 990.
Where may I obtain a copy of Form FDA 3602 (MDUFA Small Business Certification 
Request, for a Business Headquartered in the United States ?
You may obtain the PDF (portable document format) version of this form at 
https://www.fda.gov/media/106899/download.  After you complete the form you need to 
save the changes to your computer, the changes are not saved on the web.  
Where do I send my completed Form FDA 3602 (MDUFA Small Business Certification 
Request, for a Business Headquartered in the United States) and supporting materials?
The current mailing address for FDAs Medical Device User Fee Small Business 
Certification Request is located at the following web address,https://www.fda.gov/medical-
devices/premarket-submissions/reduced-medical-device-user-fees-small-business-
determination-sbd-program. 
Be sure to include complete, signed copies of all Federal (U.S.) income tax returns and 
certifications from foreign national taxing authorities that relate to your Small Business 
Certification Request.
11 Contains Nonbinding Recommendations
What do I provide if I have a foreign affiliate?
If you have a foreign affiliate, you should submit a separate Form FDA 3602A MDUFA 
Foreign Small Business Certification Request, for a Business Headquartered Outside the 
United States (which includes a National Taxing Authority Certification) for that affiliate.
What do I do if the National Taxing Authority does not provide the certification on 
Section III of Form FDA 3602A?
Form FDA 3602A contains a field for certification from a National Taxing Authority for a 
foreign business or affiliate, which serves as authentication of the gross sales and receipts for 
that business/affiliate. FDA expects you to obtain this official certification.
If the National Taxing Authority does not provide the certification, you may provide a 
written explanation of impossibility for why you were unable to obtain this certification 
along with Form FDA 3602A.  All explanations should include documentation from the 
National Taxing Authority, in English, of refusal to provide the certification  All 
.
explanations are reviewed on a case-by-case basis.  
V.  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 IV 
(Guidance for U.S. Businesses).
If you are a foreign business and wish to qualify as a small business, please follow these 
sequential steps:
1.  Obtain a copy of From FDA 3602A as described in Appendix 1.
2.  Complete Sections I and II of Form FDA 3602A (MDUFA Foreign Small Business 
Certification Request, for a Business Headquartered Outside the United States).  Note 
you need to generate your Organization ID Number (Org ID) and insert this in the proper 
field in Form FDA 3602A.  Your Org ID is separate and distinct from any other number 
that may be associated with your company.  See Section VII (Frequently-Asked 
Questions) of this guidance for instructions on generating the Org ID. 
3.  Submit Form FDA 3602A to your National Taxing Authority (the equivalent of the U.S. 
Internal Revenue Service), who then completes Section III of that form (i.e., National 
Taxing Authority Certification).  Please ensure all appropriate boxes and lines are filled 
in.
4.  The National Taxing Authority returns the updated form to you. 
12 Contains Nonbinding Recommendations
5.  Submit the completed Form FDA 3602A, with Sections I, II, and III fully completed, to 
FDA for review.  Note that Appendix 1 describes how to obtain a copy of Form FDA 
3602A and Appendix 4 of this guidance includes instructions for how to complete this 
form.  In addition, if your business has any foreign affiliates, you must send a separate 
certified Section III of Form FDA 3602A for each foreign affiliate.  If your business has 
any U.S. affiliates, you must send a Federal (U.S.) income tax return for each U.S. 
affiliate.
We recommend that you review Section VI (Guidance for Foreign Governments  How to 
Prepare a National Taxing Authority Certification) to understand the responsibility of your 
National Taxing Authority and, specifically, Section III of Form FDA 3602A.  
FDA will complete its review of your Small Business Certification Request, which includes 
your completed Form FDA 3602A and supporting evidence within 60 calendar days of 
receipt.  Upon completion of our review, we will send you a letter that indicates whether your 
business has been qualified under MDUFA as a small business.  A qualified small business is 
then eligible for a reduced or waived fee for submissions made during that FY.  If your 
business is qualified as a small business, FDAs decision letter will assign you a Small 
Business Decision number.  You should provide this number to FDA each time during the 
applicable FY that you want to receive a small business fee discount for any of your eligible 
applications or, if you qualify, when you want to obtain a free waiver for your first premarket 
application/report.
What is an affiliate?
The term affiliate is defined by Section 737(12) of the FD&C Act.  An 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 Form FDA 3602A (MDUFA Foreign Small Business 
Certification Request, for a Business Headquartered Outside the United States).   
Who is my National Taxing Authority?
Your National Taxing Authority is the government agency that collects your national income 
tax.  Please contact your national government to identify the appropriate point of contact for 
your National Taxing Authority. 
What do I do if the National Taxing Authority does not provide the certification on Section 
III of Form FDA 3602A for my business or my foreign affiliate? 
Form FDA 3602A contains a field for certification from a National Taxing Authority for a 
foreign business or affiliate, which serves as authentication of the gross sales and receipts for 
that business/affiliate.  FDA expects you to obtain this official certification.
13 Contains Nonbinding Recommendations
If the National Taxing Authority does not provide the certification, you may provide a 
written explanation of impossibility for why you were unable to obtain this certification 
along with Form FDA 3602A.  All explanations should include documentation from the 
National Taxing Authority, in English, of refusal to provide the certification  All 
.
explanations are reviewed on a case-by-case basis.  
May a foreign applicant file a Federal (U.S.) income tax return in order to qualify as a 
small business under MDUFA?
Although the law does not prohibit a foreign business from submitting a Federal (U.S.) 
income tax return, filing a Federal (U.S.) income tax return may have significant tax and 
other legal consequences beyond simply making you eligible as a small business under 
MDUFA.  FDA cannot provide advice regarding whether you should or should not file a 
Federal (U.S.) income tax return.  If you are in doubt as to whether it is advisable for you to 
file a Federal (U.S.) income tax return, you should consider consulting with qualified legal 
and tax professionals.  Additional information on Federal (U.S.) income taxation is available 
from the United States Internal Revenue Service (www.irs.gov).
Where may I obtain a copy of Form FDA 3602A (MDUFA Foreign Small Business  
Certification Request)?
You may obtain the PDF version of this form at 
https://www.fda.gov/media/106907/download. After you complete the form, you need to 
save the changes to your computer.
Where do I send my completed Form FDA 3602A (MDUFA Foreign Small Business  
Certification Request) and supporting materials?
The current mailing address for FDAs Medical Device User Fee Small Business 
Certification Request is located at the following website, h https://www.fda.gov/medical-
devices/premarket-submissions/reduced-medical-device-user-fees-small-business-
determination-sbd-program. 
Include the completed certifications from your foreign national taxing authorities and signed 
copies of all Federal (U.S.) income tax returns that relate to your Small Business 
Certification Request.
VI.  Guidance for Foreign Governments  How to Prepare 
a National Taxing Authority Certification
Qualification as a MDUFA small business allows the business to pay reduced medical device 
user fees.  The Medical Device User Fee Amendments of 2007 provide an alternative means 
for a foreign business to demonstrate that it qualifies as a MDUFA 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 
14 Contains Nonbinding Recommendations
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 businesss 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.
Form FDA 3602A (MDUFA Foreign Small Business Certification Request, for a Business 
Headquartered Outside the United States) 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 relate to your national income taxation 
system, please contact the United States Internal Revenue Services through the United States 
Embassy. 
What information should the business submit to the National Taxing Authority?
The business should send the National Taxing Authority a Form FDA 3602A (MDUFA 
Foreign Small Business Certification Request, for a Business Headquartered Outside the 
United States), with Section I and II fully 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?
15 Contains Nonbinding Recommendations
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.
VII.  Frequently Asked Questions
What is the purpose of a Small Business Decision number?
The Small Business Decision number is used by FDA to confirm that you have been 
qualified as a small business and may receive the appropriate user fee reduction or waiver 
when you submit an application that requires a user fee (as described at the FDA MDUFA 
User Fees website8).  You should use your Small Business Decision number to document that 
you have qualified as a small business.  You should include your Small Business Decision 
number when you submit a Medical Device User Fee Cover Sheet, which is available from 
the FDA User Fee System.
When will my status as a small business begin?
Your status as a small business will begin on the date of FDAs decision letter which 
qualified you as a small business.  
When will my status as a small business expire?
Your status as a small business will expire at the end of the FY for which the Small Business 
status was granted (September 30).  You should submit a new MDUFA Small Business 
Certification Request 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 (U.S.) income tax return (if 
you are a U.S. business) or your most recent certification of income from your 
national taxing authority (if you are a foreign business).
What is an Organization ID Number (Org ID)?
Org ID is a system-generated number assigned to a new organization during the User Fee 
account creation process that uniquely identifies your business in the FDA User Fee System.9
It is not the same as the Federal Employer Identification Number, Registration Number, or 
Taxpayer Identification Number.  It is important this number is correct, because the Org ID is 
used by FDA to interact with an organization to ensure proper payment of its medical device 
applications that require the payment of a user fee.  If this number is incorrect there could be 
a delay in processing your Small Business Certification reduced user fee for your application.
If you are a registered company, you should already have an organization ID number. You 
should use this one - do not create a new one.
8 Available at https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa.
9 Available at https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp?legalsel=2&ref.  
16 Contains Nonbinding Recommendations
Your Org ID may be found in the Profile section, under Business Information on the User 
Fee System MDUFA screen.10 Follow these instructions to obtain your organization number:
1.  Login to the User Fee System MDUFA screen and enter a valid user name and 
password to sign into the Medical Device User Fee Website.  Located at: 
https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp. 
2.  Click the Go button for the Medical Device User Fee (MDUFA Cover Sheets (e.g., 
PMA, De Novo, 510(k), etc.)) option, under the Cover Sheets section.
3.  Click the Profile icon located on the top of the page
4.  You will see Business Information under the Details tab. The organization ID number 
is listed below the organization name.
If your company has never paid a user fee, you should create a new User Fee System 
account.  See the FDA User Fee System (UFS) Account Creation Desk Guide located at: 
https://userfees.fda.gov/OA_HTML/mdufa_account_creation.pdf for detailed instructions.  
If you forgot your user name and/or password or a message displays "Invalid username 
and/or password" while attempting to login, you may retrieve your user name and/or 
password online by returning to the User Fee System website and clicking on the "Forgot 
User Name/Password?" link.  You will need to enter your user name and/or email address 
and then click on the "email My Password" button.  If the email address or username is valid, 
a temporary password will be sent to the user with the requested information.  If the message 
"We're sorry, but we haven't been able to locate your account information" is displayed, you 
should create a new User Fee account.
Please contact the User Fee Helpdesk at userfees@fda.gov or (301) 796-7200 if you need 
assistance obtaining your Organization ID Number (Org ID) or there are any issues with your 
account.  Be prepared to provide your organization name and address.
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 qualified you 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.
May a company request a small business determination for a prior FY? 
No, Section 738(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act states that all device 
user fees are due upon submission of device reports (such as PMA annual report) or device 
applications. A company must pay the fees before submitting their reports or applications.  
The process requires an applicant to first submit (and receive) the small business 
certification, and then submit any user fee-requiring applications in order to obtain the 
10 Available at https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp 
17 Contains Nonbinding Recommendations
reduced fee.  We have no provision for an applicant to retroactively request a small business 
status for a prior FY. 
What may happen if I submit a false Small Business Certification Request concerning 
my business?
When you make your Small Business Certification Request, you are explicitly certifying:
. . . to the best of my knowledge, the information I have provided in this 
Request is complete and accurate.  I understand that submission of a false 
request 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.
Who is the contact for the Small Business Certification Request?
The primary contact for the Small Business Certification Request is the person making this 
Certification identified in Section 1, Box 4.  If you would like to identify additional contacts, 
please identify any additional contacts on the cover letter of your Small Business 
Certification Request. To protect your confidential information, we will only communicate 
with individuals you have identified as contacts.
If I have a question, whom may I ask?
If you need additional information about becoming a MDUFA small business, contact FDAs 
Division of Industry and Consumer Education11 by email at DICE@fda.hhs.gov or by phone 
at 800-638-2041 or 301-796-7100.
VIII.  Appendix Instructions for Completion of Form 
FDA 3602 and 3602A
This appendix includes several references for use with this guidance:
11 Available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-
division-industry-and-consumer-education-dice. 
18 Contains Nonbinding Recommendations
# Appendix Instruction
1 General Instructions for Completion of Forms These are general 
instructions for downloading, 
editing and printing the 
forms (from Appendix 1)
2 Instructions for Completing Form FDA 3602  These are instructions to 
(MDUFA Small Business Certification Request,  complete Form FDA 3602 
for a Business Headquartered in the United States) (from Appendix 2)
3 Instructions for Completing Form FDA 3602A  These are the instructions to 
(MDUFA Foreign Small Business Certification  complete Form FDA 3602A 
Request, for a Business Headquartered Outside the  (from Appendix 3)
United States)
    
19 Contains Nonbinding Recommendations
Appendix 1:  General Instructions for Completion of Forms
Please complete the electronic PDF (portable document format) form.  
If you cannot complete the PDF version on your computer, you may download a paper copy 
of the form and fill out the information in clear handwriting or with a typewriter.  Please take 
care to write all numbers and digits clearly.
To complete the form with a computer: 
1)  Locate the Form FDA 3602:
https://www.fda.gov/media/106899/download 
Or locate Form FDA 3602A at:
https://www.fda.gov/media/106907/download 
2)  Download the PDF version of the form and fill it out using your computer. 
3)  Save file as Adobe Acrobat PDF File on your computer. 
4)  Open the saved PDF file on your computer.
5)  To complete the appropriate form: 
a.  Type directly onto the form.
b.  If you are unable to type directly into the form
i.  Go to the top right side of the page and Select Tool.
ii.  Click on Content.
iii.  Click on Add or Edit Text Box.
6)  Save the form that you just updated to your computer.
7)  Date and sign the form.  You may date and sign the form either using a wet (i.e. ink) or a 
valid digital signature.12
8)  Once the form is completed, print the form.
12 21 CFR 11.3(7) Electronic signature means a computer data compilation of any symbol or series of symbols 
executed, adopted, or authorized by an individual to be for the appropriate FY (submissions received by FDA from 
October 1st, through September 30th for a FY). the legally binding equivalent of the individual's handwritten 
signature.
21 CFR 11.3 (8) Handwritten signature means the scripted name or legal mark of an individual handwritten by that 
individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act 
of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal 
mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.
20 Contains Nonbinding Recommendations
Appendix 2:  Instructions for Completing Form FDA 3602 
(MDUFA Small Business Certification Request, for a 
Business Headquartered in the United States)
You should complete and submit Form FDA 3602 (MDUFA Small Business Certification 
Request, for a Business Headquartered in the United States) for the appropriate Fiscal Year 
(FY) (requests received by FDA from October 1st, through September 30th for a FY). 
Please identify the Fiscal Year for which the Small Business Certification Request is 
applicable in the upper right section of the header of the form.   
Small Business Certification Request for FY 20__
FY- October 1 through September 30
Section I  Information about the Business Requesting Small Business Status
1.  Name of business requesting MDUFA Small Business status.  Provide the full legal name 
of the business.  
When completing the Form FDA 3602 please assure the business name is the same name as 
the business name on your U.S. Federal Tax Form.  
  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 businesss Federal Employer 
Identification Number (EIN) was assigned to you by the U.S. Internal Revenue Service and 
uniquely identifies your business. 
When completing the Form FDA 3602, please ensure the Federal Employer Identification 
Number matches the Federal Employer Identification Number (EIN) on your tax form. 
2a.  The Organization ID Number (Org ID).  Org ID is a system-generated number assigned 
to a new organization during the User Fee account creation process that uniquely identifies 
your business in the FDA User Fee System.13  See Section VII (Frequently-Asked Questions) 
13 Available at https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp?legalsel=2&ref. 
21 Contains Nonbinding Recommendations
of this guidance for instructions on obtaining your Org ID; the Org ID is used by FDA to 
interact with an organization to ensure proper payment of its medical device applications that 
require the payment of a user fee.  If this number is incorrect there could be a delay in 
processing your Small Business Certification reduced user fee for an application. 
3.  Address where business is physically located.  This is the address where the business is 
physically located (i.e., the address you would give to a person who needed to travel directly 
to the businesss primary establishment). 
4.  Name of person making this Small Business Certification Request.  This is the person who 
is responsible for the accuracy and completeness of the information provided in the request 
and who must sign the Small Business Certification Request (see item 10).  This is also the 
person FDA will contact for all communications regarding your MDUFA Small Business 
Certification Request, for a Business Headquartered in the United States.
5.  Your telephone number.  This is the telephone number where FDA may reach you if we 
have a question concerning your MDUFA Small Business Certification Request, for a 
Business Headquartered in the United States.
6.  Your mailing address.  This is the address FDA will use to mail any correspondence 
regarding the Small Business Certification Request.  If your mailing address is the same as 
item 3, you may check the box instead of providing the information again in Box 6.  
7.  Your email address.  This is the email address that the FDA will use to communicate with 
you about your MDUFA Small Business Certification Request and send your decision letter.  
Our primary means of communicating with you is via email; therefore, please make sure 
your email address is correct and functioning.  If you do not have an e-mail address or 
provide one that is functioning, we will communicate by standard mail.
8.  What is your relation to the business requesting the MDUFA 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 a MDUFA 
Small Business Certification Request, for a Business Headquartered in the United States on 
behalf of the business).
9.  Have you listed all of the businesss 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.).
  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.
22 Contains Nonbinding Recommendations
10.  The applicants signature on the Form FDA 3602 in box 10 may be a wet (i.e., ink) 
signature or a valid digital signature. Complete, sign, and date the following certification.  In 
this certification, you should provide the following information:
  The name of the business that is requesting MDUFA small business status.  This 
should be identical to your response to item 1.
  Check one response to indicate whether the business has any affiliates. Please make 
sure this agrees with the response in box 9. 
o  Check the first box if the business has no affiliates and you have completed 
box 9 as This business has no affiliates.
o  Check the second box if the business has only the affiliates you listed in 
Section II of the form and you have completed box 9 as Yes.
  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 (U.S.) income tax return. Attach 
a true and accurate copy (a complete and unaltered copy) of the businesss 
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 (U.S.) income 
tax return.  Please note that the following list is not an all-inclusive list for IRS Forms 
that may contain information on your gross receipts or sales.  You should provide all 
IRS Forms that contain information on your gross receipts or sales.
IRS Form see Line Number:
Schedule C (Form 1040) 1
Schedule C-EZ (Form 1040) 1
Form 1065 1a
Form 1065-B 1a
Form 1120 1a
Form 1120-F Section II, 1a
Form 1120S 1a
Form 990 12
Any other form contact FDA
  Check the second box if the business and all 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 entitys most recent Federal (U.S.) income tax return and a true and 
23 Contains Nonbinding Recommendations
accurate copy of each affiliates most recent Federal income tax return.  
  What is the most recent tax year?
You should submit your most recent tax return.  If you submit your Small Business 
Certification Request prior to the current years due date for your taxes, you may 
submit your previous years tax return.
If you obtained an extension to file your taxes, then you may use your most recent 
return filed prior to the extension.  In this scenario, you should also include your IRS 
Form 7004: Application for Automatic Extension of Time To File Certain Business 
Income Tax, Information, and Other Returns in your application.
  The person identified in item 4 (Name of person making this request) must sign the 
Small Business Certification Request.
  Date the request (this is the date you signed the Small Business Certification 
Request).
Section II  Information about You and Your Affiliates
Section II of the form provides space for listing up to 15 affiliates; if you have more than 15 
affiliates, you may provide the additional information on one or more additional copies of 
Section II.
Lines 1 through 15:
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.
24 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 
Federal 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.  See the instruction for 
item 9 to learn where you will find this information on a Federal (U.S.) 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.
16.  Total Gross Receipts or Sales of All Affiliates.  This is the sum of the Gross Receipts or 
Sales shown in column c. of lines 1 through 15. If you have no affiliates, please enter 0.
17.  Gross Receipts or Sales of the Business Making this Small Business Certification 
Request.  This is the gross receipts or sales of the business identified in Section I, item 1.
18.  Total Gross Receipts or Sales Used to Determine Qualification as a Small Business.  
This is the sum of lines 16 and 17.  To qualify as a MDUFA 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 FD&C Act.
Once you have completed your Form FDA 3602, print and sign the form.  Mail the 
completed form and your supporting documentation (copies of the Federal (U.S.) income tax 
returns) to Medical Device User Fee Small Business Certification Request mailing address 
which is available at the following website, https://www.fda.gov/medical-devices/premarket-
submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program. 
Be sure to include complete, signed copies of all Federal (U.S.) income tax returns and 
certifications from foreign national taxing authorities that relate to your Certification.
If you need assistance, please contact the Division of Industry and Consumer Education at 
800-638-2041 or 301-796-7100 or e-mail at DICE@fda.hhs.gov.
25 Contains Nonbinding Recommendations
Appendix 3:  Instructions for Completing Form FDA 3602A 
(MDUFA Foreign Small Business Certification Request, for a 
Business Headquartered Outside the United States)
Section I  Information about the Business Requesting Small Business Status
1.  Name of business requesting MDUFA Small Business status.   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 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.
2a.  The Organization ID Number (Org ID) Org ID is a system-generated number assigned to 
a new organization during the User Fee account creation process that uniquely identifies your 
business in the FDA User Fee System.14  See Section VII (Frequently-Asked Questions) of 
this guidance for instructions on obtaining your Org ID; The Org ID is used by FDA to 
interact with an organization to ensure proper payment of its medical device applications that 
require the payment of a user fee.  If this number is incorrect there could be a delay in 
processing your Small Business Certification reduced user fee for an application.
-3.  Address where business is physically located.  This is the address where the business is 
physically located (i.e., the address you would give to a person who needed to travel directly 
to the businesss primary establishment).
4.  Name of person making this Small Business Certification Request.  This is the person who 
is responsible for the accuracy and completeness of the information provided in the request 
and who must sign the Small Business Certification Request (see item 10).  Only the head of 
your firm or your chief financial officer may make and sign the Certification; see Sections 
738(d)(2)(B)(iii) and 738(e)(2)(B)(iii) of the FD&C Act.  This is also the person FDA will 
contact for all communications regarding your MDUFA Foreign Small Business Certification 
Request for a Business Headquartered Outside the United States.
5.  Your telephone number.  This is the telephone number where FDA may reach you if we 
have a question concerning your MDUFA Foreign Small Business Certification Request for a 
Business Headquartered Outside the United States.
14 Available at https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp?legalsel=2&ref. 
26 Contains Nonbinding Recommendations
6.  Your mailing address.  This is the address that FDA will use to mail any correspondence 
to.  If your mailing address is the same as item 3, you may check the box instead of providing 
the information again in Box 6. 
7.  Your email address.  This is the email address that the FDA will use to communicate with 
you about your MDUFA Small Business Certification Request and send your decision letter.  
Our primary means of communicating with you is via email; therefore, please make sure 
your email address is correct and functioning.  If you do not have an e-mail address or 
provide one that is functioning, we will communicate by standard mail.
Section II  Information about Your Affiliates
Section II of the form provides space for listing up to 5 affiliates; if you have more than 5 
affiliates, you may provide the additional information on one or more additional copies of 
Section II.
Lines 1 through 5:
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:  
  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 business entities.
  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. 
  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 Federal 
Employer Identification Number (EIN) assigned to the affiliate by the U.S. Internal 
27 Contains Nonbinding Recommendations
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.
  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 (U.S.) 
income tax return.  Please note that the following list is not an all-inclusive list for 
IRS Forms that may contain information on your gross receipts or sales.  You should 
provide all IRS Forms that contain information on your gross receipts or sales.
IRS Form see Line Number:
Schedule C (Form 1040) 1
Schedule C-EZ (Form 1040) 1
Form 1065 1a
Form 1065-B 1a
Form 1120 1a
Form 1120-F Section II, 1a
Form 1120S 1a
Form 990 12
Any other form contact FDA
What is the most recent tax year of an affiliate headquartered in the United States?  
You should submit your most recent tax return.  If you submit your Small Business 
Certification Request prior to the current years due date for your taxes, you may use 
the previous years tax return. You may submit your previous years tax return.
If you obtained an extension to file your taxes, then you may use your most recent 
return filed prior to the extension.  In this scenario, you should also include your IRS 
Form 7004: Application for Automatic Extension of Time To File Certain Business 
Income Tax, Information, and Other Returns in your application.
6.  Total Gross Receipts or Sales of All Affiliates.  This is the sum of the Gross Receipts or Sales 
shown in column c. of lines 1 through 5. If you have no affiliates leave blank.
28 Contains Nonbinding Recommendations
7.  Gross Receipts or Sales of the Business Making this Small Business Certification Request.  
This is the gross receipts or sales of the business identified in Section I, item 1, as reported to 
your National Taxing Authority.
8.  Total Gross Receipts or Sales Used to Determine Qualification as a Small Business.  This is 
the sum of items 6 and 7.  For you to qualify for MDUFA 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 FD&C 
Act.
9.  Have you attached a separate MDUFA Foreign Small Business Certification Request, for a 
Business Headquartered Outside the United States or a Federal (U.S.) 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.).
10.  The applicants signature on the FDA Form 3602A in box 10 may be a wet (i.e., ink) 
signature or a valid digital signature. Complete, sign, and date the following certification.  In this 
certification, you should provide the following information:
  The name of the business that is requesting MDUFA 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 MDUFA Foreign Small Business 
Certification Request, for a Business Headquartered Outside the United States, 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.  Please contact your national government if 
you need assistance in identifying and contacting your National Taxing Authority. 
Your National Taxing Authority is responsible for completing Section III  National Taxing 
Authority Certification; you cannot complete this section yourself.  You are responsible for 
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identifying and contacting your National Taxing Authority.  Your National Taxing Authority 
should complete Section III, and should then return your completed MDUFA Foreign Small 
Business Certification Request for a Business Headquartered Outside the United States to you.  
You are responsible for sending your completed MDUFA Foreign Small Business Certification 
Request for a Business Headquartered Outside the United States and all required supporting 
documentation to FDA.
Once you have completed your Form FDA 3602A, print and sign the form.  Mail the completed 
form and your supporting documentation including the following to FDAs Medical Device User 
Fee Small Business Certification Request address, which is available at the following website 
https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-device-user-fees-
small-business-determination-sbd-program. 
  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 MDUFA Foreign Small Business Certification Request for each of your 
foreign affiliates.
If you need assistance, please contact the Division of Industry and Consumer Education at 
800-638-2041 or 301-796-7100 or e-mail at DICE@fda.hhs.gov.
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IX. 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:
FDA PRA Staff, 
Office of Operations, 
Food and Drug Administration, 
PRAStaff@fda.hhs.gov 
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 May 31, 2022). 
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.
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