Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
Update: July 13, 2026
The application window for FY 2026 MDUFA Small Business Requests (SBR) closed on August 1, 2026, at 4:00 PM ET. Applications submitted after this time will not be accepted for FY 2026.
The application window for FY 2027 MDUFA Small Business Requests (SBR) opened on August 1, 2026, at 4:01 PM ET.
On this page:
- What is CDRH's Small Business Determination (SBD) Program?
- Important Dates for SBRs
- How to Apply: Submitting Your SBR
- Frequently Asked Questions
- Resources
A. What is CDRH's Small Business Determination (SBD) Program?
The Medical Device User Fee Amendments (MDUFA) require the payment of a user fee for most types of medical device applications and reports, including establishment registration. MDUFA also includes certain fee reductions and waivers for qualifying small businesses. Therefore, the FDA created a Small Business Determination Program which offers qualifying small businesses benefits such as application fee reductions or waivers for these applications and reports. Eligibility depends primarily on whether the establishment falls at or below the applicable gross receipts or sales threshold specified in statute.
A business qualifies as a "small business" once FDA reviews and approves its Small Business Request (SBR) which includes submitting Form FDA 3602N (“Form 3602N”) and providing documentation demonstrating that its gross sales or receipts — including those of all affiliates — do not exceed a defined statutory threshold for the most recent tax year. The applicable threshold depends on the benefit being sought. See Table 1 below for additional details on eligibility:
- $100 million or less — Reduced Application/Report Fees
- $30 million or less — First Premarket Application/Report Fee Waiver
- $1 million or less — Annual Registration Fee Waiver
The term "affiliate" means a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly-
- one business entity controls, or has the power to control, the other business entity; or
- a third party controls, or has power to control both of the business entities.
To learn more about Medical Device User Fees for Small Businesses, please see, Medical Device User Fee Small Business Qualification and Determination - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments.
The small business benefits and eligibility criteria are summarized in Table 1 below:
Table 1. Small Business Benefits and Eligibility Criteria
| Benefit | Eligibility Criteria | Additional Details |
|---|---|---|
| Reduced Application/Report Fees | 1. $100 million or less total gross receipts or sales, including affiliates, in the most recent tax year. | To see the current standard and reduced application fees, visit the MDUFA Fees webpage. Important: Reduced fees are not available for the annual registration fee. |
| "First Premarket Application/Report" Fee Waiver | 1. $30 million or less total gross receipts or sales, including affiliates, in the most recent tax year; AND 2. Neither you nor any of your affiliates have previously submitted a "First Premarket Application/Report". | A "First Premarket Application/Report" is defined as the first:
Important: This benefit does not apply to other applications not listed here, such as 510(k) applications. |
| Annual Registration Fee Waiver | 1. $1 million or less total gross receipts or sales, including affiliates, in the most recent tax year; AND 2. Proof of financial hardship†; AND 3. Evidence that your firm has paid the annual registration fee in a prior fiscal year and registered under your owner/operator number with the FDA. | Important: If your business does not qualify, you are required to pay the full annual establishment registration fee for the current fiscal year. |
† Financial Hardship: FDA intends to grant waivers only where financial hardship is shown by a clear and objective standard, the meeting of which is publicly transparent. The only situation we are currently aware of that meets this is where the small business is in active bankruptcy. FDA believes that active bankruptcy represents financial hardship that is shown by a clear, objective standard, the meeting of which is a matter of public record. For more information, refer to the guidance document Medical Device User Fee Small Business Qualification and Determination.
B. Important Dates for SBRs
Before preparing your SBR, you should be aware of the important dates and deadlines for submitting your request. A detailed explanation of the SBR submission deadlines, SBR review and processing timelines, and SBR effective dates are listed below.
- Application Submission: All SBRs must be submitted electronically through the CDRH Portal.
- SBR Submission Dates: The FDA accepts SBRs beginning August 2 prior to the next fiscal year (which starts on October 1). For example, requests for Fiscal Year 2027 status will be accepted from August 2, 2026, through August 1, 2027.
- SBR Annual Registration Fee Waiver: Applicants must submit supporting information at least 60 days before the registration fee is due, which is December 31. Therefore, applicants must submit supporting information for this waiver between August 2 and November 1.
- Review Timeline: The FDA’s goal to complete its review of a SBR is within 60 calendar days of receipt. Once your SBR is submitted, you can view the status of your submission at any time. In the CDRH Portal, go to “Your Reviews” then select “All reviews” in the filter, that will display all items under current review. Upon completion of our review, the FDA will send the applicant a letter that indicates approval or denial of the benefits being sought.
- SBR Effective Period: Starts on October 1 or the date you receive approval, whichever is later. Small business status expires September 30 of the fiscal year it is granted. A new SBR must be submitted each fiscal year to maintain small business status.
C. How to Apply: Submitting Your SBR
IMPORTANT: All SBRs must be submitted electronically. Mailed applications will not be accepted.
An SBR is a compilation of documents you submit to support your request for “small business” status and specific benefits. To receive this status, you must prepare and submit a complete SBR to CDRH’s SBD program. The SBD program will review your SBR to determine whether your business qualifies and which program benefit(s) it is eligible to receive.
A complete SBR includes the following documents:
- A complete Form 3602N (MDUFA Small Business Request Form).
- Your signed Federal (U.S.) income tax return(s) or National Taxing Authority’s stamped certification.
- A signed Federal (U.S.) income tax return(s), and/or National Taxing Authority’s stamped certifications for each business affiliate.
- Proof of financial hardship (for registration fee waiver requests).
- Proof of a prior year’s registration fee payment (for registration fee waiver requests).
- Other supporting documents (e.g. certified translations, business name changes, etc.)
To submit an SBR, follow these 6 steps:
Organization Number (Org ID): An FDA system-generated number is given to a new organization when creating a User Fee System account. This number can be located in your User Fee System account profile under “Business Information’. Your Org ID is separate and distinct from any other number that may be associated with your business. It is not your Federal Employer Identification Number, Registration Number, or Taxpayer Identification Number. You must use the current Org ID associated with your business to complete Form 3602N.
- If your business has a User Fee System account: You will have an Org ID associated with it. Do not create a new one.
- If your business does not have a User Fee System account: You must create one.
U.S. applicants:
- Copies of the most recent U.S. Federal income tax return for your business.
- Copies of the most recent U.S. Federal income tax return for each of your affiliates located in the U.S, if applicable.
- A National Taxing Authority (NTA) (if extant) Certification for each foreign affiliate (Section III of the Form 3602N ).
NOTE: U.S. Federal income tax returns must include the dated signature of an authorized officer, partner, or member of the company. Tax returns bearing watermarks of any kind cannot be accepted (e.g., “do not file”, “client copy”, or "taxpayer's copy"). Only copies of official tax returns that were submitted to the United States Internal Revenue Service (IRS) without watermarks will be accepted.
Foreign applicants:
- Your NTA (if extant) Certification for your business (Section III of Form 3602N).
- An NTA (if extant) Certification for each foreign business affiliate (Section III of the Form 3602N).
- The most recent U.S. Federal income tax return(s) for each of your affiliates located in the U.S.
NOTE: You must report your business’ gross receipts or sales for the most recent year in both the local currency and in U.S. dollars and identify the exchange rate used in converting local currency to U.S. dollars.
If requesting an annual registration fee waiver:
- You and your affiliates’ combined gross receipts or sales cannot exceed $1,000,000 for the most recent tax year (Section II of Form 3602N), and
- Proof of financial hardship (e.g., documentation of active bankruptcy).
- FDA intends to grant waivers only where financial hardship is shown by a clear and objective standard, the meeting of which is publicly transparent. The only situation we are currently aware of that meets this is where the small business is in active bankruptcy.
- Evidence that your firm has paid the establishment registration fee for a previous fiscal year and registered under your owner/operator number with the FDA.
NOTE: Under section 738(a)(3)(B)(ii)(II) of the FD&C Act, a business that has never paid the establishment registration fee is not eligible for the fee waiver. For more information about the registration fee waiver requirements, refer to the guidance, Medical Device User Fee Small Business Qualification and Determination.
- Navigate to the FDA Forms webpage and search “3602N”. Download and complete Form 3602N.
- Alternatively, you may download and print out the form and either use a typewriter or complete it by hand. Any method is acceptable as long as it is legible. Scan the completed form and upload it to your computer.
- Once complete, save or print your copies of Section III and send them to the appropriate NTA for completion, when applicable.
- Submit the completed Form 3602N via the CDRH Portal.
For step-by-step guidance on completing Form 3602N, please watch the SBD Program’s video series below. Transcripts and printable slides are available for download through CDRH Learn.
- Introduction
- Form 3602N - Section I
- Form 3602N - Section II
- Form 3602N - Section III
- Form 3602N - Section IV
- Common Submission Errors
If you don’t have a CDRH Portal account:
- You must register for an account.
- Important: CDRH uses Okta for identity verification and single sign-on purposes when users register for a CDRH Portal account. Account registration and password reset requests will come from an email ending in okta.com.
If you have a CDRH Portal account:
- Log in to the CDRH Portal.
- Enter your login information.
After logging in:
- Hover over the left navigation panel and select “Create a Request”.
- Select the “Start” button next to “Small Business Determination request” to begin.
- Complete the required fields and upload all documents.
- The first email will acknowledge that your request has been received. You will be pre-assigned an SBR number. That number becomes activated if approved as a “small business”.
- You will receive additional correspondence if there are issues with your request and upon completion of FDA’s review. These messages will also be available in the CDRH Portal.
- You may log into the CDRH Portal to securely communicate with FDA about your application. Click on your SBR and go to the “Messages” tab to create a new message.
NOTE: Check your spam and junk folders for any correspondence from the agency.
The CDRH Portal provides the status of your SBR in near real-time.
Statuses are generally defined as below:
- Processing: When a request is submitted, and a virus scan is in progress.
- Reviewing: When the FDA is reviewing a request.
- On hold: When reviewers have flagged issues and need additional information from the applicant.
- Finished: When an application is either Approved or Denied. A determination letter will be provided at the completion of the review.
- Withdrawn: When an application is withdrawn by the applicant.
D. Frequently Asked Questions:
The FDA accepts SBRs beginning August 2 prior to the next Fiscal Year (which starts on October 1). For example, requests for Fiscal Year 2027 status will be accepted from August 2, 2026 through August 1, 2027.
You may qualify for a waiver of the registration fee, if your business can demonstrate that it meets all three (3) criteria below:
- Your most recent Federal (U.S.) income tax return(s), including the returns of your affiliates, show $1,000,000 or less in gross receipts or sales, AND
- You provide proof of financial hardship (e.g., documentation of active bankruptcy), AND
- You provide evidence that the establishments for which you are seeking a waiver have, under your owner/operator ID with FDA, previously registered and paid the associated registration fees
For purposes of the registration fee waiver, for actively registered firms, the FDA accepts SBRs through November 1. For example, requests for FY 2027 status (which runs from October 1, 2026, through September 30, 2027) will be accepted from August 2, 2026, through November 1, 2026.
Refer to The Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments guidance for additional information.
No. The statute does not contain a transferability provision pursuant to which a small business finding and qualification for the fee waiver or reduction could be transferred to another entity. For example, if the owner/operator of a device establishment, found to be a small business, is acquired by another entity and that acquiring entity submits an application, the applicant must pay the full fee, unless it obtains its own small business determination. Additionally, a third-party consultant who submits an application on behalf of its client is not the applicant and may not qualify for a reduction or waiver.
The business that will be paying the fee and listed as the applicant of any submission requiring a user fee will need to submit their own SBR and obtain approval to be eligible for the reduced user fee. The firm’s information and Org ID within their certification letter must match that of the submission requiring the user fee.
There is no fee associated with submitting an SBR.
The SBD number is a system-generated number pre-assigned to a business that applies to the SBD Program. If approved, the SBD number is linked to your User Fee account and will be denoted for required payments (e.g. premarket submission or annual registration). The number is also utilized when creating a MDUFA Cover Sheet for premarket submissions.
No. A U.S. business, and its affiliates, cannot qualify as a small business under MDUFA if it has not submitted a Federal (U.S.) income tax return. 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 or National Taxing Authority Certification of all affiliates). Regarding the registration fee waiver, Section 738(a)(3)(B)(ii)(III) requires a small business to submit its most recent Federal income tax return to support its eligibility for the registration fee waiver.
Yes, if your business has been operational for less than a year:
U.S. businesses:
- You can provide the FDA with a copy of your (U.S.) income tax return that includes less than 1 year. The dates that the (U.S.) income tax return encompasses should be identified on the tax return. In addition, please provide documentation identifying the business’s formation to justify the lack of a full year’s tax return.
OR
- If you operate as a sole proprietorship, you may submit your personal (U.S.) income tax return. Your (U.S.) income tax return must identify your business and its gross receipts and sales, under Schedule C, within your personal 1040 U.S. Federal Tax Return.
Foreign businesses:
- If you have been operating for less than one year, you may submit a Form 3602N, Section III, National Taxing Authority Certification that covers a period of less than one year. The certification must clearly identify the applicable dates. Along with the completed National Taxing Authority Certification, you should also provide documentation showing your business formation date (e.g., Memorandum of Incorporation, Articles of Association) to support your explanation of why a full year tax information is not available.
OR
- If you operate as a sole proprietorship, you may submit your personal tax return. The tax return must show your business name and gross receipts or sales, as reported to your National Taxing Authority, and must be certified by your National Taxing Authority.
If your business has a foreign affiliate, you should submit a completed Section III - National Taxing Authority Certification of Form 3602N certified by the National Taxing Authority for that affiliate. A National Taxing Authority is the government agency that collects the national income tax in the country where your affiliate is located. Please contact that national government to identify the appropriate point of contact for the National Taxing Authority where your affiliate is located.
If you live in a jurisdiction without a National Taxing Authority (NTA) you may submit evidence of your gross sales and receipts (e.g., end of fiscal year financial statements or shareholder reports) to show that you fall below the applicable threshold to qualify for a small business fee waiver or reduction. You should submit a signed affidavit from an authorized officer, partner, or member of the company stating that no NTA exists in your country and attesting that all submitted information is true and accurate. The evidence will be reviewed on a case-by-case basis.
If you submit an application before the FDA has determined you qualify as a small business, you are required to pay the standard (full) amount of any fee that applies. The 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 SBD number from the FDA.
E. Resources
- Medical Device User Fee Small Business Qualification and Determination - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments
- Form 3602N
- CDRH Learn
- CDRH Portal
- MDUFA User Fees
- MDUFA User Fee Cover Sheet
- User Fee System
Contact
If you have any questions about the program or would like to refer prospective small businesses to the program, please direct them to the Division of Industry and Consumer Education via email at DICE@fda.hhs.gov.