Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
Update: July 30, 2025
As of November 1, 2024, all Small Business Requests (SBR) must be submitted electronically. For more information on the CDRH Portal, visit the FDA webpage Send and Track Medical Device Premarket Submissions Online: CDRH Portal.
Starting on Aug. 1, 2025 (for Fiscal Year 2026 and later), all SBRs will be required to use Form 3602N, which replaces Forms 3602 and 3602A for U.S. businesses and businesses headquartered outside the U.S.
This SBD program update is a step forward to enhance efficiency in submitting and tracking these SBRs. More information about this process is below in the section titled “How do I submit a Small Business Request using the CDRH Portal?”
On this page:
- What is CDRH's Small Business Determination Program?
- How to submit a Small Business Request using the CDRH Portal?
- How can I view the status of my submission?
- What is the fee for a Small Business Request?
- Frequently Asked Questions
- Resources
What is CDRH's Small Business Determination Program?
CDRH's Small Business Determination program qualifies a business as a "small business."
A “small business” is defined as a business, including its affiliates, whose gross sales or receipts do not exceed $100 million, $30 million, or $1 million, for the most recent tax year, depending on the benefit being sought.
Qualified small businesses, including all affiliates, with gross sales or receipts not exceeding $100 million, are eligible for a reduced fee for some types of CDRH submissions that require a user fee.
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 application types eligible for a reduced small business user fee are:
- Premarket Notification (510(k))
- De Novo request
- Premarket Applications, including:
- Premarket Report (PMR)
- PMA/BLA supplements and PMA annual reports
- 30-day-Notices
- 513(g) Requests for Information
In addition, a small business is eligible for a "first premarket application/report" fee waiver, if the business/affiliate gross receipts or sales are no more than $30 million. The "first premarket application/report" is defined as the first PMA (including Modular PMA), BLA, PDP, or PMR received by the FDA from a business entity or any of its affiliates.
A small business may qualify for a waiver of the registration fee if the business and its affiliates have gross receipts or sales of no more than $1 million, can demonstrate that paying the registration fee would represent a financial hardship, and have proof of a prior year’s registration fee payment.
The establishment registration fee is not eligible for a reduced small business fee.
How do I submit a Small Business Request (SBR) request using the CDRH Portal?
IMPORTANT: As of November 1, 2024, all Small Business Requests must be submitted electronically.
To submit and track an SBR, follow these 6 steps:
- Tax documentation: Refer to the small business guidance document for specific details.
Note: You should provide the completed, signed, and dated U.S. Federal income tax returns for the most recent tax year for your U.S. business including its affiliates, as well as a certified Section III of Form 3602N for foreign businesses and affiliates.
- Organization ID number (Org ID): An FDA system-generated number is given to a new organization when they create a User Fee System account. The Org ID is not the same as the Federal Employer Identification Number, Registration Number, or Taxpayer Identification Number.
- For instructions on how to create or find your Org ID, please review the FDA User Fee System Account Creation Desk Guide.
- Download Form 3602N and save it as a PDF:
The person to fill out these forms should be the official correspondent, as identified in Section I, Boxes 4 and through 7 of Form FDA 3602 and 3602A.
You may also download and print out the form and either use a typewriter or complete by hand. Any method is acceptable as long as it is legible. Then, scan the completed form and upload it to your computer.
- Log into the CDRH Portal.
- Enter your login information, if you have an active account.
- If you do not have an account, register for an account through the CDRH Portal. 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.
- Select “Create a Request” in the left navigation panel.
- Select the “Start” button next to “Small Business Determination request” to begin.
- Complete the required fields and upload all documents.
- Submit your SBR.
- The first email will confirm that your request has been received.
- You will receive additional emails, if there are issues with your request and upon completion of FDA’s review and you may log in to the portal to securely communicate with FDA about your application.
The portal provides the status of your SBR and other requests in near real-time.
Statuses are generally defined below:
- Processing: When a request is submitted, and a virus scan has been completed.
- 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 by the reviewer.
- Withdrawn: When an application is withdrawn by the applicant.
How can I view the status of my submission?
In the CDRH Portal, you can view the status of your submission at any time.
Upon completion of our review, FDA will send a message via the portal that indicates whether or not the business has been qualified as a small business.
In the CDRH Portal, you can view the status of your submission at any time.
What is the fee for a Small Business Determination request?
There is no fee associated with the submission of a Small Business Request.
Frequently Asked Questions:
The FDA accepts Small Business Requests beginning August 1 prior to the next Fiscal Year (which starts on October 1). For example, requests for Fiscal Year 2026 status will be accepted from August 1, 2025 through September 30, 2026.
You may qualify for a waiver of the registration fee if:
- your business, including its affiliates, has gross receipts or sales of $1 million or less in the most recent tax year,
- you can demonstrate that paying the registration fee would represent a financial hardship (for example, proof your business is in active bankruptcy), and
- you have proof that you had paid the registration fee in a prior fiscal year.
For purposes of the registration fee waiver, for actively registered firms, the FDA accepts SBRs through October 31. For example, requests for FY 2026 status (which runs from October 1, 2025, through September 30, 2026) will be accepted from August 1, 2025, through October 31, 2025.
No. For purposes of application fee waivers or reductions, the law provides that “an applicant shall pay the higher fees established by the Secretary each year, unless the applicant submits evidence that it qualifies” for a waiver or the lower fee rate. See sections 738(d)(2)(B) and 738(e)(2)(B) of the FD&C Act. Similarly, for purposes of the registration fee waiver, FDA may grant a waiver of the registration fee for an establishment for a fiscal year if FDA “finds that the establishment is a small business and paying the fee for such a fiscal year represents a financial hardship to the establishment.” See Section 738(a)(3)(B)(ii)(II) of the FD&C Act.
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 firm that will be paying for and listed as the applicant of any submission requiring a user fee will need to submit their own Small Business Request 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.
The Org ID (also known as Organization ID Number) uniquely identifies a business in the FDA User Fee System. The Org ID is a system-generated number assigned to a new organization during the account creation process. It is not the same as the Federal Employer Identification Number, Registration Number or Taxpayer Identification Number.
What if my business has a user fee account?
If your business has a user fee account, you will have an Org ID associated with it. Do not create a new one. Please use the current Org ID.
A business's Org ID may be found in the "Profile" section, under "Business Information" on the User Fee System MDUFA screen. Follow these instructions to locate the Org ID:
- Login to the User Fee System MDUFA screen and enter a valid username and password to sign into the Medical Device User Fee website.
- 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.
- Click the Profile icon located on the top of the page.
- The number listed there is the businesses' Org ID number.
What if my business has never paid a user fee?
Your business should create a new User Fee System account. See the FDA User Fee System (UFS) Account Creation Desk Guide for detailed instructions.
The Org ID is used by the FDA as a unique identifier when interacting with an organization to ensure proper payment of its medical device applications that require the payment of a user fee.
No. A U.S. business, including its affiliates, cannot qualify as a small business under MDUFA if they have 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.
If you have been in business for less than a year, 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 businesses formation to justify the lack of a full year’s tax return.
You may submit your personal (U.S.) income tax return. Your (U.S.) income tax return must identify your business and their gross receipts or sales, under Schedule C, within your personal 1040 U.S. Federal Tax Return.
If you have a foreign affiliate, you should submit a MDUFA Foreign SBR (which includes a National Taxing Authority Certification) 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.
A certification from a National Taxing Authority, if extant, is required to authenticate the gross sales or receipts for a foreign business or affiliate. See Sections 738(a)(3)(B)(ii)(IV),738(d)(2)(B)(iii) and 738(e)(2)(B)(iii) of the FD&C Act.
If you live in a jurisdiction without a National Taxing Authority, 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 relevant applicable threshold to qualify for a small business fee waiver or reduction. FDA plans to review evidence on a case-by-case basis to determine whether you qualify for a small business fee waiver or reduction.
If you submit an application before the FDA has determined you qualify as a small business, you will be 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 Small Business Decision number from the FDA.
Yes, the small business status expires on September 30 of the fiscal year in which it is granted. A new MDUFA Small Business Request must be submitted and approved each fiscal year in order to qualify as a small business. For example, a business that obtains small business status on October 7, 2025 will have this status through September 30, 2026.
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.