Get Form Fda 3602a. Mdufa Foreign Small Business

Filling out the FORM FDA 3602A is a crucial step for businesses headquartered outside the United States seeking small business status under the Medical Device User Fee Act (MDUFA). This guide provides clear, step-by-step instructions to assist you in completing the form accurately and efficiently.

Follow the steps to successfully complete your MDUFA Foreign Small Business Certification Request.

1. Press the ‘Get Form’ button to access the form. This will allow you to download and open the document in a suitable editor or PDF viewer.
2. Identify the fiscal year for which your Small Business Certification Request applies. Enter this information at the top right section of the form header.
3. In Section I, provide all information about the business requesting small business status, including the full legal name, Organization ID Number (Org ID), physical address, and key contact details.
4. Continue in Section II by listing all affiliates (up to 5) along with their corresponding Taxpayer ID Numbers and Gross Receipts or Sales.
5. Sum the Gross Receipts or Sales of all affiliates in Section II, and record the total in the provided space.
6. Certify the accuracy of the information provided by completing, signing, and dating the certification statement at the end of Section II.
7. For Section III, submit your completed form to your National Taxing Authority for their certification. Ensure they complete the required information.
8. After receiving the completed form back from the National Taxing Authority, review it for completeness and accuracy. Then, print and sign the final version.
9. Mail the finalized FORM FDA 3602A along with all necessary supporting documentation to the designated FDA address.
10. Once your application is complete, monitor its status and keep copies of all documents submitted for your records.

Start filling out your FORM FDA 3602A online today to ensure timely processing of your small business certification.