FDA Releases FY 2027 MDUFA Fees

FDA Releases FY 2027 MDUFA Fees

New 510(k), De Novo, PMA & Establishment Registration Costs Are Here! Is Your Regulatory Budget Ready?

Effective Date: October 1, 2026 – September 30, 2027

The U.S. Food and Drug Administration (FDA) has published the Medical Device User Fee (MDUFA) rates for Fiscal Year (FY) 2027. The new fees apply to medical device submissions received by the FDA between October 1, 2026, and September 30, 2027.

The Medical Device User Fee Amendments of 2022 (MDUFA V) authorize the FDA to collect user fees for premarket submissions and annual establishment registration. These fees help support the FDA’s review of medical device applications while maintaining performance goals for timely review of submissions. (U.S. Food and Drug Administration)

FY 2027 Medical Device User Fees

Annual Establishment Registration Fee: $13,785

The following table summarizes the FDA’s FY 2027 user fees and compares them to the 2026 user fees for the most common medical device submissions and annual establishment registration.

*Small business fees are available only to firms that qualify under the FDA Small Business Determination (SBD) Program. (U.S. Food and Drug Administration)

Who Must Pay FDA User Fees?

FDA user fees apply to manufacturers submitting certain premarket applications, including:

• 510(k) Premarket Notifications
• De Novo Classification Requests
• Premarket Approval (PMA) Applications
• PMA Supplements
• Product Development Protocols (PDP)
• Certain Biologics License Applications (BLAs)
• 513(g) Requests for Information
• Annual Establishment Registration

The applicable fee is determined by the date the FDA receives the submission, not the date it is prepared or mailed. FDA will not begin its substantive review until the applicable user fee has been paid in full. (U.S. Food and Drug Administration)

Small Business Fee Reductions

Medical device companies may qualify for significantly reduced FDA submission fees through the FDA’s Small Business Determination (SBD) Program.

Generally, businesses (including affiliates) with gross receipts or sales of $100 million or less may qualify for reduced application fees. Certain first-time PMA applicants meeting statutory requirements may also qualify for a waiver of the first PMA application fee. Annual establishment registration fees are generally not reduced, except in limited hardship situations authorized under MDUFA V. (U.S. Food and Drug Administration)

Planning Ahead for FY 2027

Manufacturers planning to submit a medical device to the FDA after October 1, 2026 should:

• Budget for the new FY 2027 FDA user fees.
• Apply early for Small Business Determination if eligible.
• Ensure user fee payments are completed before submission.
• Verify that FDA establishment registration is renewed on time.
• Plan submission schedules carefully if attempting to submit before or after the annual fee change.

Proper planning can help avoid unnecessary delays in FDA acceptance and review.

How MDI Consultants Can Help

MDI Consultants has been assisting medical device manufacturers with FDA regulatory compliance since 1978. Our regulatory professionals can assist with:

• FDA regulatory strategy
• Importer on Record
• 510(k) Premarket Notifications
• De Novo Classification Requests
• Premarket Approval (PMA) Applications
• FDA Establishment Registration and Device Listing
• Small Business Determination (SBD) applications
• FDA eSTAR preparation
• Quality Management System (QMSR) compliance
• FDA deficiency response preparation
• U.S. Agent and Official Correspondent services

Whether you are preparing your first FDA submission or expanding your product portfolio, our experienced consultants can help you navigate the FDA regulatory process efficiently.

Need Assistance?

If you have questions regarding the FY 2027 FDA medical device user fees or need assistance preparing an FDA submission, contact MDI Consultants at info@mdiconsultants.com or use our contact form https://mdiconsultants.com/contact/
Our team can help you determine the appropriate regulatory pathway, prepare your submission, and ensure compliance with current FDA requirements.