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Get Form Fda 3602. Fy 2015 Mdufa Small Business Qualification And Certification - Fda
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How to use or fill out the FORM FDA 3602. FY 2015 MDUFA Small Business Qualification And Certification - Fda online
This guide provides clear and comprehensive instructions for completing the FORM FDA 3602, necessary for businesses seeking small business status under the MDUFA for fiscal year 2015. By following these steps, users can ensure accurate submission and eligibility for reduced or waived fees on medical device submissions.
Follow the steps to complete the FORM FDA 3602 online.
- Click ‘Get Form’ button to obtain the FORM FDA 3602 and open it in your preferred editor.
- Section I: Provide the business information claiming MDUFA Small Business status. Include the full legal name, Federal Employer Identification Number (EIN), physical address, contact number, and email address of the business. Indicate your relation to the business and whether there are any affiliates.
- Confirm if all business affiliates are listed in Section II of the form. This is essential as it affects the qualification for small business status.
- Complete the Certification section, ensuring the business name matches item 1. Indicate whether the business has affiliates, and affirm that gross receipts or sales are within the required limit. Attach a copy of the most recent Federal income tax return.
- In Section II, list up to 15 affiliates, providing each affiliate's name, Taxpayer ID Number, and gross receipts or sales from their Federal income tax return.
- Calculate and provide the total gross receipts or sales for all affiliates, the gross receipts or sales for the business making the certification, and the overall total. This total must not exceed $100 million.
- Review the form for completeness and accuracy, then sign and date the certification at the bottom of Section I. Ensure that the signature is from the person identified in item 4.
- Once complete, save the changes, download the form, and print copies as needed for records or mailing purposes.
Complete your FORM FDA 3602 online today to ensure your small business qualifies for essential fee reductions!
The 180-day period for review of a PMA starts on the date of filing. FDA will refuse to file the application for substantive review if a PMA application does not meet a minimum threshold of acceptability.
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