FDA Small Business Certification

Published On - March 15, 2023

I3CGlobal FDA 510k
FDA Small Business Certification

FDA Small Business Certification

FDA Small Business Certification: Medical Device User Fee Small Business Qualification and Certification refers to the process by which a company can demonstrate to the FDA that they qualify as a small business, allowing them to pay significantly reduced fees when submitting medical device applications under the Medical Device User Fee Amendments (MDUFA) regulations; essentially, it’s a way for small businesses to access discounted fees for their device submissions to the FDA.

Who are qualified for FDA Small Business Certification?

To qualify for a reduced small business fee, you must meet the definition of a “small business,” which is having gross receipts or sales of no more than $100 million for the most recent tax year. If you have any affiliates, you need to include their gross receipts or sales in your total, which must also be no more than $100 million.

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What is the process involved in FDA Small Business Qualification and Certification?

Step 1. Gather necessary documents and information
Step 2. Fill out the form you downloaded for small business qualification and certification (Form 3602 for U.S. businesses and/or 3602A for foreign businesses) using your computer.
Step 3. Log into the CDRH Portal.
Step 4. Create a new request.
Step 5. Check your email for an automated notification from the FDA.
Step 6. Check the status of your submission by logging into the CDRH portal.

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What are the necessary Documents required for submitting an FDA Small Business Application?

  1. Tax documentation
  2. Organization ID number (Org ID),
  3. For U.S. Small Business Qualification and Certification, search and select form: FDA 3602A
  4. For Foreign Small Business Qualification and Certification, search and select form: FDA 3602A

The person to fill out these forms should be the official correspondent, as identified in Section I, Boxes 4 and through 7 of Form FDA 3602 and 3602A.

Download Form FDA-3602 >

We are FDA 510k Consultants and US Agents. Send us your enquiries for more information.
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