FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

MedDevice Startups Staff · Jul 30 · 2 min read · Via Federal Register: FY2027 rates

FDA published FY2027 device user fee rates on July 30, 2026, effective for submissions received October 1, 2026 through September 30, 2027. The standard 510(k) fee is $28,653, up from $26,067, and the small business rate is $7,163. A De Novo costs $191,020, or $47,755 for a small business. An original PMA is $636,732, or $159,183 small business. A 513(g) classification request runs $8,596 or $4,298. The inflation-adjusted total revenue amount is $507,905,000.

The establishment registration fee is the line that hurts a pre-revenue company: $13,785, up 20.7 percent, with no small business reduction. A waiver exists only for firms with gross receipts of $1,000,000 or less. Small business status for the submission fees requires gross receipts or sales no greater than $100 million including affiliates, and the determination must be approved before the submission goes in, not after. Filing the SBD request in August for an October submission is the difference between $7,163 and $28,653.

This is MDUFA V's last year. The draft MDUFA VI commitment letter rewrites the fee base for FY2028, and the two prior reauthorizations moved the 510(k) fee 125 percent and 56 percent in a single year.

Questions & Answers

How much is the FDA 510(k) user fee in fiscal year 2027?

The FY2027 standard 510(k) fee is $28,653 and the small business fee is $7,163, effective October 1, 2026. The FY2026 rates were $26,067 and $6,517.

What is the FDA establishment registration fee for fiscal year 2027?

The annual establishment registration fee is $13,785 for FY2027, up from $11,423 in FY2026. There is no small business reduction on this fee, though a waiver exists for firms with gross receipts of $1,000,000 or less.

How does a startup qualify for FDA small business user fee rates?

A company qualifies with gross receipts or sales of no more than $100 million for the most recent tax year, including affiliates, and must file a small business determination request and have it approved before submitting.

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