The Medical Device User Fees have been announced for FY2027. The Federal Register (FR) Notice can be found here: MDUFA FY2027. See the Lachman Blog for additional user fee blogs: GDUFA, BSUFA, PDUFA, ADUFA/AGDUFA, and Outsourcing.

In addition to the inflation adjustment, which is always expected, further adjustments were required to meet the inflation adjusted total revenue as outlined in MDUFA V. This resulted in an increase across the board for both Standard and Small Business of 9%, with the exception of establishment fees, which increased by 17% for both Standard and Small Businesses (versus 7% and 23% respectively, last FY).

Under MDUFA V, fees are all calculated as a percentage of the standard fee for a premarket application. These are outlined in the MDUFA FY2027 Federal Register Notice. The small business fee is 50% of the standard (full) fee for the submission.

Unlike most of the other User Fee Programs, MDUFA has a category for Small Businesses, which qualify for significantly reduced fees. How does one qualify as a Small Business for the purpose of Medical Device Fees? The FR Notice states that if your business, including affiliates, have gross receipts of <$100 million for the most recent tax year you may qualify. There are additional waivers that may apply to your first premarket application if your business, including affiliates, have gross receipts of <$30 Million. For FY27, FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to applicants that qualify if FDA finds that the establishment is a small business and paying the fee for such a year represents a financial hardship to the establishment as determined by FDA. For the purpose of the annual registration fee waiver, a small business is defined as one <$1,000,000 gross receipts or sales per the most recent tax returns (including its affiliates). For more information on obtaining such waivers, see FDA’s final Guidance for Industry issued in July 2025, Medical Device User Fee Small Business Qualification and Determination | FDA which describe FDA’s current thinking on the topic. Note, you must submit information to qualify as a small business for each fiscal year in order to pay the reduced fees. Please see the FR notice, Section V for additional information on what and how to submit information or reach out to Lachman Consultants who can guide you through this process.

As stated in FR Notice, the new user fees will be effective October 1, 2026. To avoid delay in review of your application, you must pay the application fee at the time the application is submitted to FDA. For periodic reporting for PMAs, you will be invoiced at the end of the quarter in which your PMA periodic report is due. Companies that do not manufacture any product other than a licensed biologic are required to register in the Blood Establishment Registration (BER) system. FDA’s Center for Biologics Evaluation and Research (CBER) will send establishment registration fee invoices annually to these companies.

All other establishment registrations are paid through the FDA Unified Registration and Listing System (FURLS).