什么是美国小型企业项目？如何提交小型企业申请？

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:

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 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.

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.

Complete the FDA Forms for Small Business Certification 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:

View the CDRH Learn Module: How to Complete Form FDA 3602 

Review The Medical Device User Fee Small Business Qualification and Certification: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments

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.