Medical Device User Fee Rates for Fiscal Year 2027
Published Date: 7/30/2026
Notice
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2027, which apply from October 1, 2026, through September 30, 2027, and provides information on how the fees for FY 2027 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
FY2027 Medical Device Fee Price Increase
If you submit medical device applications to FDA between October 1, 2026 and September 30, 2027, the standard premarket application fee is $636,732 for FY2027. Other FY2027 standard fees include a panel-track supplement at $509,386 (80% of the standard fee), a de novo request at $191,020 (30%), a 510(k) at $28,653 (4.5%), and an annual establishment registration fee of $13,785.
Small Business Fee Reductions and Waivers
If your firm (including affiliates) has gross receipts or sales of $100 million or less in its most recent tax year, you may qualify for reduced small business fees; if gross receipts or sales are $30 million or less you may also qualify for a waiver of the fee for your first premarket application or premarket report. For the FY2027 small business fee rate or waivers you must submit the required documentation at least 60 days before any applicable fee is due, and FY2026 small business status expires at close of business on September 30, 2026 so you must re-qualify for FY2027.
Payment Timing and Method Requirements
FDA requires the correct FY2027 fee to be received at the time you submit an application between October 1, 2026 and September 30, 2027, or the application will not be accepted for filing or review. Payments must be in U.S. currency from a U.S. bank (Pay.gov/ACH or credit card for balances under $25,000; ACH only for balances over $25,000; wire transfers allowed but must include the unique user fee ID), and FDA records the application receipt date as the later of the document room receipt or the date the U.S. Treasury recognizes the payment.
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Key Dates
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