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Begin by filling out the 'Sponsor' section with your company name and address. Ensure accuracy as this information is crucial for identification.
In the 'Contact' field, provide the name and contact details of the individual responsible for regulatory affairs. This ensures that communication regarding your submission is streamlined.
Complete the 'Device Name' section by entering both the trade name and common/usual name of your device. This helps in categorizing your submission correctly.
Fill in the 'Predicate Device' information, including its common/usual name and classification details. This establishes a comparison basis for your device's equivalence.
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What is the user fee cover sheet for FDA Form 3397?
What is the PDUFA User Fee Cover Sheet? Form FDA 3397, the PDUFA user fee cover sheet, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to help FDA track payments.
What does the FDA use user fees for?
In exchange for paying user fees, industry receives from FDA a commitment to meet certain performance goals, such as completing premarket review within a specified timeframe. Prior to each five-year reauthorization cycle, FDA and industry negotiate the performance goals, which are finalized in a written agreement.
How to pay the FDA user fee?
The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card. Make an online payment at .
What is the user fee charge?
A user fee is a charge imposed by the government for the primary purpose of covering the cost of providing a service, directly raising funds from the people who benefit from the particular public good or service being provided.
How much does PMA cost?
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)
form 3601
MDUFA loginMDUFA fees 2026FDA User fee loginGDUFA cover sheetFDA user Fee portalMDUFA Fees 2025FDA User Fee 2025FDA MDUFA goals
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3) The signed cover letter must be written on letterhead and include the purpose of the submission, contact information (including phone number and email
This section presents selected portions of the MDUFA commitment letter that explain commitments related to process improvements. cover letter and the complete
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