FDA's medical device user fee rates for fiscal year 2027 took effect on 1 October 2026, and the number that will land on a budget line before anyone reads the regulatory science is the invoice: a standard 510(k) now costs $28,653 to file, a standard PMA tops $636,000, and the annual fee just to keep an establishment registered rose again — this time with no small-business discount attached to soften it.

The number that hits every device firm, not just filers

Submission fees scale with how often a company files; the annual establishment registration fee does not. Every firm that manufactures, prepares, propagates, compounds, processes, repackages or relabels a device for US distribution owes it once a year, filers and non-filers alike, and FY2027's $13,785 — up $2,362 from FY2026's $11,423 — carries no percentage-of-revenue small-business rate the way submission fees do. The one discretionary relief valve, a hardship waiver tied to gross receipts or sales of $1 million or less, does not apply to an initial registration. For a small device maker with no pending submission this year, the registration line is the one MDUFA cost it cannot plan around or discount down.

Where the increase comes from

MDUFA fee rates are not set submission-by-submission from scratch each year; they are derived from a statutory base revenue amount for the fiscal year, adjusted for inflation, then allocated across submission types by formula. FY2027's base revenue amount under the current MDUFA V authorization is $418,343,000 before inflation adjustment — a 14% increase over the FY2026 base estimate of $366,486,300. That base is then compounded with the statute's payroll and non-payroll inflation adjustment factors before FDA publishes the per-submission dollar figures that filers actually see. The mechanism is why a single year's jump can outpace general inflation: the base itself stepped up for FY2027, and the inflation adjustment compounds on top of it.

What this means for FY2027 planning

For sponsors budgeting FY2027 submissions, the practical read is to plan on roughly a 10% increase across standard 510(k), PMA, panel-track supplement and De Novo fees relative to FY2026, confirm small-business qualification status early since the discount gap between standard and small-business rates widens in dollar terms even as the percentage stays fixed, and budget the establishment registration fee as a fixed annual cost with no submission-volume offset. This is also the last full fiscal year under the current MDUFA V fee structure: FDA's draft MDUFA VI recommendations, covering FY2028 through FY2032, are still working through the statutory comment and negotiation process this site covered in July, and MDUFA V authority itself expires 30 September 2027.

Frequently asked questions

When did the FY2027 rates take effect?

1 October 2026, running through 30 September 2027, under FDA's Medical Device User Fee Amendments (MDUFA) notice at Docket No. FDA-2026-N-7492, published in the Federal Register on 30 July 2026 (91 FR 48134).

What are the headline fee changes?

The standard 510(k) premarket notification fee rises to $28,653 (small business: $7,163). A standard PMA, product development protocol, panel-track-ineligible PMA supplement, or BLA fee rises to $636,732 (small business: $159,183), up from $579,272 in FY2026. A panel-track supplement rises to $509,386 (small business: $127,347), and a De Novo classification request rises to $191,020 (small business: $47,755). Trade reporting puts the increase at roughly 9.9-10% across most standard submission types.

What happened to the establishment registration fee?

It rose from $11,423 to $13,785 — a $2,362 increase — and, unlike submission fees, it carries no statutory small-business discount. The only relief available is a discretionary hardship waiver for firms with gross receipts or sales of $1 million or less, which does not cover an initial registration.

Why did fees go up this much?

FY2027's statutory base revenue amount under MDUFA V is $418,343,000 before inflation adjustment — 14% higher than the FY2026 base estimate of $366,486,300 — and that base amount is then compounded with the annual payroll and non-payroll inflation adjustment factors set out in the statute before FDA publishes the final per-submission rates.

Sources & further reading

  1. FDA, “Medical Device User Fee Rates for Fiscal Year 2027”, Federal Register, 30 July 2026, 91 FR 48134 (Docket No. FDA-2026-N-7492) — public-inspection copy. federalregister.gov
  2. RAPS Regulatory Focus, “FDA Unveils FY 2027 User Fee Rates” — the roughly 10% increase across standard submission types. raps.org
  3. Pure Global Regulatory Affairs, “FDA FY 2027 Medical Device User Fees: Full Fee Table” — the complete FY2027 rate table with FY2026 comparisons. pureglobal.com
  4. MedDeviceGuide, “FDA Medical Device User Fees FY 2027: MDUFA Rate Table Guide” — corroborating 510(k), PMA and establishment registration figures. meddeviceguide.com
  5. Operon Strategist, “FDA Medical Device User Fee MDUFA FY 2027” — FY2026 comparison figures for PMA, panel-track supplement and De Novo fees. operonstrategist.com

Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.