FOR CDRH WEB TEAM
UPDATE existing page – Reduced Medical Device User Fees: Small Business Determination (SBD) Program | FDA
CDRH New: No
Metadata: No changes
Update: July xx, 2024
Beginning August 1, 2024, the FDA will only accept Small Business Determination (SBD) requests for Fiscal Year 2025 and forward electronically. All documents to support an SBD application must be submitted through the Customer Collaboration Portal (CDRH Portal). See section, “How to submit a Small Business Determination Request?”
This SBD Program update is a step forward in meeting the Medical Device User Fee Amendments of 2022 (MDUFA V) commitments of using technology to enhance efficiency and transparency in reviewing industry submissions.
How to submit a Small Business Determination Request using the CDRH Portal?
What is the fee for a Small Business Certification Determination Request?
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.
Follow these six steps:
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
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.
Obtain your Organization ID number (Org ID).
The Org ID 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. The Org ID is not the same as the Federal Employer Identification Number, Registration Number, or Taxpayer Identification Number.
For instructions on how to obtain or retrieve your Org ID, please review FDA User Fee System (UFS) Account Creation Desk Guide.
Download the appropriate form(s): Form FDA 3602 or 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.
Complete the FDA forms for Small Business Determination Request (Form 3602 and/or 3602A).
To complete the appropriate form:
Type directly onto the form that you downloaded onto your computer.
If you are unable to type directly into the form:
Go to the top right side of the page and Select "Tool."
Click on "Content."
Click on "Add or Edit Text Box."
Save the form that you just updated to your computer.
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.
For
detailed step-by step instructions to complete the Form FDA 3602
and Form FDA 3602A:
View the applicable CDRH Learn modules under “Start Here/The Basics!"
Upload all documents (tax documentation and FDA Forms) to the CDRH Portal.
Note:
In your account, you will go to “Create a Request” to
initiate an SBD request.
The FDA will typically complete its review of the Small Business Determination 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.
In the CDRH Portal you can view the status of your submission at any time.
There is no fee associated with the submission of a Small Business Determination request.
Q.
When can I submit my MDUFA Small Business Determination request?
The
FDA accepts Small Business Determination requests beginning August 1
prior to next Fiscal Year (which starts on October 1). For example,
requests for Fiscal Year 2025 status will be accepted from August 1,
2024 through September 30, 2025.
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 certification. 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 Determination request and obtain certification to be eligible for the reduced user fee. The firm’s information and Organization ID (Org ID) within their certification letter must match that of the submission requiring the user fee.
Q.
What is an Organization ID number (Org ID)?
The
Organization ID Number (Org ID) 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.
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
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' 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 ID used?
The
Org ID is used by 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.
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 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.
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 Determination request, for a
Business Headquartered Outside the United States, including 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 Determination
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, 2024 will have this status
through September 30, 2025.
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.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Scherf, Uwe |
| File Modified | 0000-00-00 |
| File Created | 2024-09-06 |