Get Fda 3602 2019-2025

The FDA 3602 form is essential for businesses seeking to certify their status as small businesses under the Medical Device User Fee Amendments (MDUFA). This guide will provide clear, step-by-step instructions on how to effectively complete the FDA 3602 online.

Follow the steps to complete the FDA 3602 form online.

1. Click ‘Get Form’ button to obtain the form and open it in your preferred electronic document software.
2. Identify the fiscal year for which you are requesting the Small Business Certification. Clearly indicate this in the upper right section of the form header.
3. In Section I, provide the name of your business as it appears on your Federal tax form.
4. Enter your business's Federal Employer Identification Number (EIN) in the specified field, ensuring it matches your tax documentation.
5. Provide the physical address where your business operates, including details necessary for someone to locate the business.
6. List the name and contact details of the person responsible for this certification. Include their position in the business.
7. In the field for affiliate information, indicate if your business has affiliates. If yes, confirm that they are listed in Section II.
8. Complete the certification statement at the end of Section I. Check the correct response box regarding your affiliates and gross receipts.
9. Proceed to Section II to list any affiliates, providing each entity's name, Taxpayer ID number, and total gross receipts or sales.
10. Calculate the total gross receipts for all listed affiliates, as well as the gross receipts for your business, ensuring they meet the qualification criteria.
11. Once you have filled in all required fields accurately, print the completed form. Sign and date it before submission.
12. Submit your completed FDA 3602 form, along with required supporting documents, to the designated FDA mailing address.
13. If assistance is needed while filling out the form, contact the Division of Industry and Consumer Education.

Start completing your FDA 3602 form online today to take advantage of the benefits available for small businesses.