Device Makers: Brace for FDA's FY2027 Fee Sticker Shock
Published Date: 7/30/2026
Notice
Summary
Starting October 1, 2026, medical device companies will see updated user fees for submitting their products to the FDA and for annual registrations. These fees help the FDA review and monitor medical devices, with special discounts available for small businesses. If you’re in the medical device world, get ready to budget for these new costs through September 30, 2027!
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
Department and Agencies
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