Medical Devices

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


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, 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 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 four 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. Complete the FDA Forms for Small Business (Form 3602 and/or 3602A).
    • The applicable Small Business Certification Request Form(s)
    • Form FDA 3602 - for businesses headquartered in United States (U.S.)
    • Form FDA 3602A - for foreign businesses/affiliates headquartered Outside the U.S.)
    • Note: Section III of Form FDA 3602A must be completed by the National Taxing Authority (NTA) (the equivalent of the U.S. Internal Revenue Service) for a foreign business and any foreign affiliates.
  4. Send all documents from Steps 2 and 3 (tax documentation and FDA Forms) to FDA at this address:

    FY 20__ MDUFA Small Business Qualification
    Division of Industry and Consumer Education
    10903 New Hampshire Avenue
    Building 32, Room 3215
    Silver Spring, MD 20993
    U.S.A.

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

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. 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. 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.

Page Last Updated: 08/01/2018
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