FDA Announces FY 2027 Medical Device User Fees

The U.S. Food and Drug Administration (FDA) has announced its Medical Device User Fee Amendments (MDUFA) fee rates for Fiscal Year 2027, which take effect October 1, 2026, through September 30, 2027.

For medical device companies planning a U.S. submission, the new fees should be incorporated into regulatory timelines and budgets now.

Annual Establishment Registration Fee: $13,785

These represent increases over FY 2026. For example, the standard 510(k) fee increases from $26,067 to $28,653, while the standard De Novo fee increases from $173,782 to $191,020

Small Business Determination Can Deliver Significant Savings

FDA's Small Business Determination (SBD) Program allows qualifying companies to receive substantially reduced fees for many medical device submissions.

For FY 2027, a qualifying company would pay $7,163 instead of $28,653 for a 510(k) and $47,755 instead of $191,020 for a De Novo request.

For eligible companies, obtaining a Small Business Decision before submission can significantly reduce the cost of entering the U.S. market.

Companies should address SBD eligibility early, as an eligible applicant must have its FDA Small Business Decision number and include it on the applicable Medical Device User Fee Cover Sheet to receive the reduced fee.

Timing Matters

FDA user fees are based on the fiscal year in which the Agency receives the submission. Therefore, submissions received on or after October 1, 2026, will be subject to FY 2027 rates.

This makes regulatory planning particularly important for companies currently preparing a 510(k), De Novo, PMA, or other FDA submission.

How RQMIS Can Help

RQMIS has been helping medical product companies navigate regulatory, quality, and clinical requirements since 1996.

Our team can support companies throughout the FDA process, including:

• FDA regulatory strategy and product classification
• Pre-Submission (Q-Sub) strategy and preparation
• 510(k), De Novo, and PMA submissions
• Small Business Determination applications
• FDA Establishment Registration and Device Listing
• Clinical and statistical strategy
• Quality Management System development
• Software and medical device cybersecurity support
• FDA communications and ongoing regulatory support

Choosing the right regulatory pathway—and understanding the associated costs before development and submission—can help avoid unnecessary delays, testing, and expense.

With the FY 2027 MDUFA fees taking effect October 1, 2026, companies planning U.S. market entry should review their regulatory strategy, submission timeline, and potential eligibility for FDA's Small Business Determination Program now.