FDA 510(k) Fees & Review Timeline (Fiscal Year 2025)

Budgeting for a 510(k) submission involves more than just development costs. Understanding the mandatory FDA user fees and the official review timeline is essential for planning your path to market. This page breaks down the costs and timelines for Fiscal Year 2025 (October 1, 2024 - September 30, 2025).

510(k) Application Fees for FY 2025

The FDA updates the Medical Device User Fee Amendments (MDUFA) fees annually. For a 510(k), you must pay this fee before submission, or your application will be rejected.

Company Size	510(k) Fee for FY 2025
Standard Business	$21,760
Certified Small Business	$5,440

To qualify for the small business fee, your company (including all affiliates) must have gross receipts or sales of no more than $100 million for the most recent tax year. You must apply to and be certified by the FDA's Center for Devices and Radiological Health (CDRH) to claim this status *before* you submit your 510(k).

The Cost of Delays Far Exceeds the Application Fee.

An RTA hold or an Additional Information request can delay your revenue by months. Cruxi's AI platform helps you submit a complete, high-quality application the first time, minimizing the risk of costly delays and saving you money in the long run.

Accelerate Your Time-to-Market

The Official FDA 510(k) Review Timeline

The FDA's goal is to make a MDUFA decision on a 510(k) submission within 90 calendar days. However, this is "FDA time," which stops and starts. The total elapsed time is often much longer.

Breakdown of the 90-Day Clock

Day 1

Submission Received: The "FDA clock" starts.

Day 7

Acceptance Review: FDA performs an administrative check to ensure the submission is complete. If not, they issue a "Refuse to Accept" (RTA) hold.

Day 15

RTA Decision: You are notified if your submission is accepted or placed on RTA hold. If on hold, the FDA clock stops until you resubmit.

Day 60

Substantive Review & AI Request: The FDA conducts a detailed scientific review. If they have questions, they will issue an "Additional Information" (AI) request. The FDA clock stops. You have 180 days to respond.

Day 90

Final Decision: If there are no holds, the FDA aims to issue a final decision (e.g., Substantially Equivalent) within 90 total FDA days.

The most common delay occurs at the AI Request stage. A thorough, well-organized, and clear submission, like one prepared using an eSTAR-compliant platform, dramatically reduces the likelihood of receiving an AI request, keeping the clock running and shortening your total time to clearance.

Factors That Affect Your Actual Timeline

Several factors can extend your total time to clearance beyond the 90-day FDA clock. Submission completeness is the biggest: an RTA hold resets the clock and can add weeks or months. Device complexity matters—software, combination products, or novel technologies often trigger more questions. The quality of your predicate comparison and test data also influences how many AI rounds you receive. Planning for 4–8 months from submission to clearance is realistic for many devices; complex submissions can take longer.

When Are Fees Due?

The 510(k) user fee must be paid before or at the time of submission. The FDA will not accept your application without proof of payment. Payment is made through the FDA's user fee payment system. If you qualify for the small business fee, ensure you have your CDRH Small Business Certification in hand before submitting—retroactive fee adjustments are not available.

References & Citations

This page is based on official FDA guidance and MDUFA fee schedules.