Fda small business qualification form 3602 2014-2025

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The document outlines the requirements and procedures for businesses headquartered in the United States to apply for small business status under the Medical Device User Fee Amendments (MDUFA) for fiscal year 2015. It includes sections for providing business information, affiliate details, and certification of gross receipts or sales not exceeding $100 million. The form must be completed and submitted to the FDA along with supporting tax documents to qualify for reduced or waived fees on medical device submissions.

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We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is a small business certification?

Obtaining a certification allows businesses to take advantage of federal contracting opportunities awarded only to certified small businesses (commonly referred to as set aside opportunities). The first step is to determine whether your business qualifies as a small business.

What does the FDA consider a small business?

What are a small business and very small business? A small business is a business, including any affiliates and subsidiaries, employing fewer than 500 full-time equivalent employees.

What is a small business qualification for the FDA?

ing to the FDA, a small business is defined as a company, including its affiliates, with gross receipts and sales under $100 million for the most recent tax year. The deadline to file your FDA Small Business Determination (SBD) Application and secure cost savings for 2025 FDA User Fees is October 1, 2024.

Do I need to register my food business with the FDA?

L. 107-188) added section 415 to the Federal Food, Drug, and Cosmetic Act (FDC Act). Section 415 of the FDC Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA.

What companies need to register with the FDA?

Domestic and foreign establishments that manufacture, repack, or re-label drug and biologic products, including vaccines, are required to register with the FDA.

fda form 3602

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