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Click ‘Get Form’ to open the MDUFA Small Business Certification Request in the editor.
In Section I, provide the full legal name of your business as it appears on your U.S. Federal Tax Form. Ensure accuracy to avoid processing delays.
Enter your Taxpayer Identification Number and Organization ID Number if applicable. This information is crucial for identifying your business.
Fill in the physical address of your business, along with contact details including telephone number and email address for communication purposes.
Complete Section II by listing any affiliates, if applicable. Provide their names, Taxpayer ID Numbers, and Gross Receipts or Sales as reported on their most recent tax returns.
Review all entries for accuracy before signing and dating the form. You can sign digitally or print and sign manually.
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Consulting Fees for US agent services (typically an annual fee ranging from $250-$1,500) Any additional consulting fees if the FDA contacts your agent. Who is responsible for payment of FDA User Fees ($11,423 for FY 2026 FDA User Fee)
How much is the FDA annual registration fee?
Annual Establishment Registration Fee: $11,423 Most establishments must pay the establishment registration fee. For more information, see Who Must Register, List and Pay the Fee and When to Register and List.
How much does MDUFA cost?
■ 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. A very small business is a business (including any subsidiaries or affiliates) that averages less.
How much does it cost to get a medical device FDA approved?
The Food and Drug Administration (FDA) assesses and collects user fees to supplement Congressional appropriations. In fiscal year (FY) 2022, user fees represented 46% ($2.9 billion) of FDAs total budget of $6.2 billion.
fda form 3602a
Mdufa business certification request pdfMdufa business certification request formFDA small business waiverFDA 3602Small business designationFDA definition of small business
If requested by the CA, the manufacturer must provide the technical documentation in the requested language of the European Union (Medical Device Coordination
Jun 6, 2016 A medical device company must obtain FDAs prior approval or clearance before marketing many medical devices in the United States. The Center
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