Contains Nonbinding Recommendations
Draft Not for Implementation
Select Updates for the 
Medical Device User Fee Small 
Business Qualification
and Certification Guidance
______________________________________________________________________________
Draft Guidance for Industry and
Food and Drug Administration Staff
DRAFT GUIDANCE
This draft guidance document is being distributed for comment purposes 
only.
Document issued on February 22, 2024.
You should submit comments and suggestions regarding this draft document within 60 days 
(standard), days of publication in the Federal Register of the notice announcing the availability 
of the draft guidance. Submit electronic comments to https://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 listed in the notice of availability that publishes in the Federal Register.
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) by email at ocod@fda.hhs.gov or at 1-800-
835-4709 or 240-402-8010.
When final, this guidance will update and supersede the applicable sections of 
Medical Device User Fee Small Business Qualification
and Certification, issued on August 1, 2018.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research Contains Nonbinding Recommendations
Draft Not for Implementation
Preface
Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
GUI00018007 and complete title of the guidance in the request.
CBER
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., WO71, Room 3128, Silver Spring, MD 20993, 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-bloodbiologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances. Contains Nonbinding Recommendations
Draft Not for Implementation
Table of Contents
I.  Introduction ............................................................................................................................. 1
II.  Policy ...................................................................................................................................... 2 Contains Nonbinding Recommendations
Draft Not for Implementation
Select Updates for the
1 
Medical Device User Fee Small 
2 
Business Qualification 
3 
and Certification Guidance 
4 
5   
6  ______________________________________________________________________________ 
Draft Guidance for Industry and 
7 
Food and Drug Administration Staff 
8 
9   
10  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
11  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person 
12  and is not binding on FDA or the public.  You can use an alternative approach, if it satisfies 
13  the requirements of the applicable statutes and regulations.  To discuss an alternative 
14  approach, contact the FDA staff or Office responsible for this guidance, as listed on the title 
15  page.  
16   
I.  Introduction 
17 
18  FDA has developed this draft guidance to propose select updates to the FDA guidance document, 
19  Medical Device User Fee Small Business Qualification and Certification1 (Small Business 
20  Guidance). The existing Small Business Guidance remains, in its current form, the Agencys 
21  current thinking on the topic until this draft guidance is finalized. FDA intends to incorporate this 
22  draft guidance into one final guidance document, after obtaining and considering public 
23  comment on these select updates. The proposed sections referenced below are intended to 
24  enhance applicable sections of the existing Small Business Guidance. The sections of the 
25  existing Small Business Guidance that are not affected by this select update will not be 
26  substantively changed and will remain the Agencys current thinking on the topic. 
27   
28  On December 29, 2022, the Food and Drug Omnibus Reform Act of 2022 (FDORA) was 
29 signed into law as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328. 
30 Section 3309 of the Omnibus Small Business Fee Waiver amends section 738(a)(3)(B) of the 
31 Federal Food, Drug, and Cosmetic Act (FD&C Act) to give FDA discretion, beginning in fiscal 
1https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-
business-qualification-and-certification
1 Contains Nonbinding Recommendations
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32  year (FY) 2025, to waive the establishment registration fee for device establishments that are 
33  small businesses, if FDA determines that paying such fee represents a financial hardship.  
34   
35  Based on this amendment, FDA is proposing updates to the guidance that describe how small 
36  businesses can show financial hardship to qualify for a small business registration fee waiver. 
37  For purposes of this new fee waiver provision, small business is defined as those that reported 
38  $1,000,000 or less of gross receipts or sales in their most recent Federal income tax return.2 
39  Additionally, FDA is proposing updating the guidance to reflect how applicants based in 
40  jurisdictions without a National Taxing Authority (NTA) need not submit a certification from an 
41  NTA to be eligible for fee waivers or reductions.3  
42   
43  FDAs guidance documents, including this draft guidance, do not establish legally enforceable 
44  responsibilities. Instead, guidances describe the Agencys current thinking on a topic, and should 
45  be viewed only as recommendations, unless specific regulatory or statutory requirements are 
46  cited. The use of the word should in Agency guidance means that something is suggested or 
47  recommended, but not required.  
48   
II.  Policy 
49 
50   
51  FDA is proposing to modify the language in the second paragraph in Section II.A of the Small 
52  Business Guidance to read: 
53   
54  The establishment registration fee (registration fee) may be waived if a business (owner or 
55  operator) meets the conditions described in Sections III (for domestic businesses) and IV (for 
56  foreign businesses) below to receive a small business registration fee waiver.  There are no 
57  reduced fees for registration.    
58   
59  FDA is proposing to change the title of Section III to Small Business Fees and Waivers. and to 
60  modify the introductory paragraph to Section III of the Small Business Guidance and add 
61  language to Section III.D:  
62   
63 This section identifies the MDUFA User Feeschedule, explains the benefits of qualifying as a small 
64 business, defines the first premarket application/report fee waiver, and defines the small business
65 registration fee waiver.
66
67 D. Small Business Registration Fee Waiver
68
2See Section 738(a)(3)(B)(ii)(I) of the FD&C Act.
3See Section 738(a)(3)(B)(ii)(IV) of the FD&C Act, as amended by section 3309(a) of FDORA/FY23 Omnibus, 
which allows a firm to qualify as a small business by providing a certification, in English, from the national taxing 
authority, if extant, of the country in which the establishment or, if applicable, affiliate is headquartered (emphasis 
added). See also, sections 738(d)(2)(B)(iii) and 738(e)(2)(B)(iii) of the FD&C Act, as amended by sections 3309(b) 
and 3625(d) of FDORA/FY23 Omnibus, respectively.
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69  Applicants that report $1,000,000 or less in gross receipts or sales in their most recent 
70  Federal (U.S.) income tax return (including the returns of its affiliates) may be eligible to 
71  receive a waiver of the fee required for their annual registration (excluding the initial 
72  registration) if FDA determines that paying the annual registration fee represents a 
73  financial hardship to the applicant.  FDA intends to combine and update the forms FDA-
74  3602 and FDA-3602A to request both minimal information needed to evaluate an SBD 
75  hardship determination and evidence of prior paid registration fees. Under section 
76  738(a)(3)(B)(ii)(V) of the FD&C Act, applicants seeking a small business registration fee 
77  waiver must submit any supporting information at least 60 days before the fee is due. 
78  Section 738(a)(3)(B)(ii)(V) additionally states FDAs decision regarding whether an 
79  applicant may receive a registration fee waiver is not reviewable. 
80   
81  FDA is proposing to add the following language at the end of Section IV Guidance for U.S. 
82  Businesses. 
83   
84  How can I demonstrate financial hardship and receive a small business 
85  registration fee waiver? 
86   
87  FDA may, but is not required to, grant a waiver of the fee for annual registration to 
88  applicants that qualify as a small business if FDA finds that the establishment is a small 
89  business and paying the fee for such year represents a financial hardship to the 
90  establishment as determined by FDA.  FDA intends to grant waivers only where financial 
91  hardship is shown by a clear and objective standard, the meeting of which is publicly 
92  transparent.  The only situation we are currently aware of that meets this is where the 
93  small business is in active bankruptcy. FDA believes that active bankruptcy represents 
94  financial hardship that is shown by a clear, objective standard, the meeting of which is a 
95  matter of public record. Thus, if you are seeking the small business registration fee 
96  waiver, we recommend you provide the following: 
97   
98    your most recent Federal (U.S.) income tax return(s) showing $1,000,000 or less 
99  in gross receipts or sales (including affiliates);  
100    evidence that the establishments for which you are seeking a waiver have, under 
101  your owner/operator ID with FDA, previously registered and that the associated 
102  registration fees have been paid; and  
103    evidence that you have filed a petition for bankruptcy in United States Bankruptcy 
104  Court and that the bankruptcy is currently active (debts have yet to be discharged 
105  or a reorganization plan has not been confirmed.)  
106   
107 FDA is proposing to add the following language at the end of Section V. Guidance for Foreign
108 Businesses:
109
110 How can I demonstrate financial hardshipand receive a small business 
111 registration fee waiverifI am located outside of the United States?
112
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113  FDA may, but is not required to, grant a waiver of the fee for annual registration to 
114  applicants that qualify as a small business if FDA finds that the establishment is a small 
115  business and paying the fee for such year represents a financial hardship to the 
116  establishment as determined by FDA.  FDA intends to grant waivers only where financial 
117  hardship is shown by a clear and objective standard that is publicly transparent. The only 
118  situation we are currently aware of that meets this is where the small business is in active 
119  bankruptcy. FDA believes that active bankruptcy represents financial hardship that is 
120  shown by a clear, objective standard, the meeting of which is a matter of public 
121  record.  Thus, if you are applying for the small business registration fee waiver, we 
122  recommend you provide the following: 
123   
124    The most recent income tax return(s) submitted to your National Taxing 
125  Authority showing $1,000,000 or less in gross receipts or sales (including 
126  affiliates);  
127    evidence that each establishment for which you are seeking a waiver have 
128  previously registered and paid the registration fee under your owner/operator ID 
129  with FDA; and  
130    evidence that you have filed your jurisdictions equivalent of a United States 
131 bankruptcy action, including evidence the applicant has initiated the action (i.e., 
132  evidence analogous to a United States bankruptcy petition) and evidence that the 
133  bankruptcy action is active.  
134   
135  What if I live in a jurisdiction without a National Taxing Authority?  
136   
137  You may submit evidence of your gross sales and receipts (e.g., end of fiscal year financial 
138  statements or shareholder reports) to show that you fall below the relevant threshold to 
139  qualify for a small business fee waiver or reduction. FDA plans to review evidence on a 
140  case-by-case basis to determine if it is sufficient to show that you qualify for a small 
141  business fee waiver or reduction.  
142   
143  FDA is proposing to add the following language to the end of Section VII. Frequently Asked 
144  Questions 
145   
146  If my firm qualifies as a small business, may I take advantage of the reduced fees 
147  or fee waivers on behalf of another entity? 
148   
149  No.  For purposes of application fee waivers or reductions, the law provides that an 
150  applicant shall pay the higher fees established by the Secretary each year unless the 
151  applicant submits evidence that it qualifies for a waiver or the lower fee rate.  See 
152  sections 738(d)(2)(B) and 738(e)(2)(B) of the FD&C Act. Similarly, for purposes of the 
153 registration fee waiver, FDA may grant a waiver of the registration fee for an 
154 establishment for a year if FDA finds that the establishment is a small business and 
155 paying the fee for such year represents a financial hardship to the establishment.  See 
156 section 738(a)(3)(B)(ii)(II).  
157
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158  The statute does not contain a transferability provision pursuant to which a small business 
159  finding and qualification for the fee waiver or reduction could be transferred to another 
160  entity. For example, if the owner/operator of a device establishment found to be a small 
161  business is acquired by another entity, and that acquiring entity submits an application, 
162  the applicant must pay the full fee unless it obtains its own small business determination.  
163  Additionally, a third-party consultant who submits an application on behalf of its client is 
164  not the applicant and may not qualify for a reduction or waiver. 
165   
166  As a small business that can show financial hardship, will I be liable for the annual 
167  registration fee? 
168   
169  Under 21 CFR Part 807, establishments must register annually with FDA.4   If you have 
170  registered a facility under your owner/operator ID with FDA previously and you have 
171  been granted a small business registration fee waiver, you will not be required to pay the 
172  annual registration fee for that year.  
173   
174 How often will FDA grant the small business registration feewaiver?
175
176 If FDA grants the small business fee waiver, it does not intend to grant this waiver to the 
177 same entity in relation to the circumstances that gave rise to the waiver.
178
4For more information see https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-
list-and-pay-fee
5