MDUFA Fee Calculator

Calculate FDA MDUFA fees, small business discounts, and realistic submission timelines with milestone tracking. This free tool saves consultants 1-2 hours per project by automatically calculating current fee amounts, eligibility for discounts, and project timelines based on submission type.

How It Works

The MDUFA Fee Calculator provides comprehensive fee and timeline calculations:

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Fee Calculation: Calculates current MDUFA fees for 510(k), De Novo, PMA, IDE, Q-Submission, and other submission types based on the current fiscal year fee schedule published by FDA.
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Small Business Discount: Determines eligibility for small business fee reductions (75% discount for small businesses, 50% for very small businesses) based on annual revenue and employee count.
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Timeline Estimation: Generates realistic project timelines with key milestones including RTA review period, substantive review timeline, and typical FDA response times based on submission type and complexity.
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Milestone Tracking: Identifies critical project milestones including fee payment deadlines, submission dates, FDA review periods, and expected decision dates.
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Fee Schedule Updates: Automatically updates with current fiscal year fee amounts, ensuring calculations are always based on the latest FDA fee schedule.

What It Does

This tool generates comprehensive fee and timeline reports:

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Fee Breakdown: Detailed calculation of base fees, small business discounts, and total fees due for each submission type
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Timeline Projection: Realistic timeline estimates with key milestones, FDA review periods, and expected decision dates
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Payment Deadlines: Critical payment deadlines and fee submission requirements to avoid delays
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Small Business Eligibility: Assessment of small business status and applicable fee discounts with eligibility criteria
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Exportable Report: Professional PDF fee and timeline report with your branding that can be shared with clients or included in project proposals

⏱️ How It Saves Time

Saves 1-2 hours per project by automating fee and timeline calculations:

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Automated Fee Calculation: Eliminates 30-45 minutes of manually looking up current fee amounts and calculating fees for different submission types
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Small Business Assessment: Saves 15-30 minutes of determining small business eligibility and calculating applicable discounts
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Timeline Generation: Automates 30-45 minutes of researching typical FDA review times and creating project timelines with milestones
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Report Generation: Provides ready-made fee and timeline report structure, saving 15-30 minutes of document creation

ROI: for FDA 510k Consultants handling 10+ projects per month, this tool saves 10-20 hours monthly while ensuring accurate fee calculations and realistic timelines.

Perfect For

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FDA 510k consultants preparing project proposals and cost estimates for clients
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Regulatory teams budgeting for FDA submissions and planning project timelines
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Firms providing regulatory strategy services with fee and timeline planning
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FDA 510k consultants advising clients on small business fee reduction eligibility

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This tool is completely free for verified FDA 510k consultants in the Cruxi network. Join thousands of regulatory professionals who use our tools to save 20+ hours per week.

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✓ No subscription fees • ✓ All 15 tools included • ✓ Export with your branding