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  6. Reduced Medical Device User Fees: Small Business Determination (SBD) Program
  1. Premarket Submissions: Selecting and Preparing the Correct Submission

Reduced Medical Device User Fees: Small Business Determination (SBD) Program

Update: February 21, 2024

The FDA issued the draft guidance: “Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance.” The FDA intends to incorporate the updates proposed in this draft guidance into the final guidance, “Medical Device User Fee Small Business Qualification and Certification” after obtaining and considering public comment on the proposed updates. When finalized, this select update will describe how small businesses can show financial hardship to qualify for a small business registration fee waiver. 

On this page:

What is CDRH's Small Business Program?

CDRH's Small Business Program determines whether a business is qualified and certified as a "small business" and eligible for a reduced fee for some types of CDRH submissions that require a user fee.

The application types eligible for a 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, 30-day-notices, and 513(g) request for classification information.

A small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.

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.

The establishment registration fee is not eligible for a reduced small business fee.

How to submit a Small Business Certification Request?

Follow these six steps:

  1. Review the Small Business Guidance.
    Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments
  2. Gather your tax documentation.
    • See the guidance for specific details.
    • Note: You should provide the complete, signed and dated U.S. Federal income tax returns for the most recent tax year for a U.S. business and all U.S. Affiliates. See guidance for details.

  3. Obtain your Organization ID number (Org ID).

    The Org ID uniquely identifies a business in the FDA User Fee Website. The Org ID is a system-generated number assigned to a new organization during the account creation process. The Org ID is not the same as the Federal Employer Identification Number, Registration Number, or Taxpayer Identification Number.

    For instructions how to obtain or retrieve your Org ID, please review FDA User Fee System (UFS) Account Creation Desk Guide.

  4. Download the Appropriate Form(s): Form FDA 3602, Form FDA 3602A

    • Download the PDF version of the form and fill it out using your computer.

    • Save the file as an Adobe Acrobat PDF File on your computer.

    • Open the saved PDF on your computer.

  5. Complete the FDA Forms for Small Business Certification Request (Form 3602 and/or 3602A).

  6. Send all documents (tax documentation and FDA Forms) to the FDA at this address:

    Address
    FY 20__ MDUFA Small Business Qualification
    Small Business Certification Program
    10903 New Hampshire Avenue
    Building 66, Room 5305
    Silver Spring, MD 20993
    U.S.A.

What is the review timeline for a Small Business Certification Request?

The FDA will complete its review of the Small Business Certification Request within 60 calendar days of receipt. Upon completion of our review, we will send the business a letter that indicates whether or not the business has been qualified as a small business.

What is the fee for a Small Business Certification Request?

There is no fee associated with the submission of a Small Business Certification Request.

Frequently Asked Questions:

Q: When can I submit my MDUFA Small Business Certification?
A Small Business Certification is granted for a Fiscal Year and expires at the end of that Fiscal 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 Fiscal Year in which they plan to submit a medical device application that requires a user fee. A Fiscal Year runs from October 1 through September 30 of the following year. For example, Fiscal Year 2021 runs from October 1, 2020 through September 30, 2021.

The FDA accepts Small Business Certification Requests beginning August 1 prior to next Fiscal Year (which starts on October 1). For example, requests for Fiscal Year 2021 status (which runs from October 1, 2020 through September 30, 2021) will be accepted from August 1, 2020 through September 30, 2021.

A Small Business Certification Request for the next Fiscal Year received before August 1 will not be accepted. Please plan your request strategy accordingly.

Q. As a small business, am I eligible for a waiver of the annual registration fee?
No, the FDA is not currently able to grant an annual registration fee waiver. The FDA will announce before we begin accepting requests for annual registration fee waivers. 

Q. May I use my Small Business Determination to pay the reduced fee for a submission where the applicant is a different firm?
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. 

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.

Q. What is an Organization ID number (Org ID)?
The Organization ID Number (Org ID) uniquely identifies a business in the FDA User Fee Website. 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.

Q. How to locate a business Organization ID number (Org ID)?

What if my business has a user fee account?
If your business has a user fee account, you will have an Org ID. 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:

  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.
  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. The number listed there is the businesses' organization 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.

Q. How is the Org Number ID used?
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.

Q. Can I obtain a MDUFA Small Business Certification if I have not filed 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 Cortication 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.

If you have been in business for less than a year, you can provide the FDA with a copy 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.

Q. What do I provide if I am headquartered in the Unites States and 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, Section III that has been completed by the affiliates National Taxing Authority.

Q. My National Taxing Authority won’t provide the certification on Section III of Form FDA 3602A. What can I do?
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. The 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 their refusal to provide the certification. All explanations are reviewed on a case-by-case basis.

Q. What if I pay the MDUFA user fee prior to submitting an application to the FDA that requires a user fee?
If you submit an application before the FDA has qualified you 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.

Q. Does a Small Business Determination status expire?
Yes, the small business status expires on September 30 of the fiscal year in which it is granted. A new MDUFA Small Business Certification Request must be submitted and approved each fiscal year to qualify as a small business. For example, a business that obtains small business status on October 7, 2018 will have this status through September 30, 2019.

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.

Resources

 
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