The US Food and Drug Administration (FDA) recently announced that as of November 1, 2024, all applications for the 

Small Business Designation (SBD) program will be submitted online.

This adjustment will provide medical device companies with a more efficient and convenient application experience. 

The FDA's move aims to simplify the application process and improve the approval efficiency, so that more eligible small 

businesses can quickly enjoy the preferential policy of exempting medical device users from fees. 

Next, we will provide you with a detailed explanation of the revised application process and the required materials.

1. Confirm enterprise qualification: The company needs to confirm if it meets the definition of a small business, which means 

annual total revenue and sales do not exceed $100 million.

2. Prepare application materials: The following is a list of required documents for applying for the SBD program: 

   - Basic company information: Company name, address, contact details, etc.

   - Financial data: Proof that the company's annual total revenue and sales meet the small business criteria.

   - Application form: Detailed listing of the types of user fees intended to be exempted.

3. Submit online: Submit the SBD application through the CDRH portal online, ensuring all materials are complete and accurate.

4. Await approval: FDA typically completes review within 60 days after receiving the SBD application and notifies applicants of 

the result.

SUNGO Free Service Supports 510K Customers

Despite changes in application methods, SUNGO remains committed to providing free small business qualification application 

services for 510K customers including:

- Professional consultation: Comprehensive answers to questions related to SBD projects.

- Material preparation assistance: Assisting you in preparing all necessary application materials.

- Online submission guidance: One-on-one guidance to help you smoothly complete online applications.

- Approval tracking: Real-time monitoring of approval progress to ensure smooth advancement.