MDUFA V Medical Device User Fees for Fiscal Year 2027

1. Key takeaways

According to the rate table published on FDA’s MDUFA Fees page, for fiscal year 2027 (October 1, 2026 to September 30, 2027) the annual establishment registration fee is USD 13,785, an increase from the FY2026 figure of USD 11,423. The standard 510(k) fee is USD 28,653 (small business USD 7,163), the PMA fee is USD 636,732 (small business USD 159,183), and the De Novo fee is USD 191,020 (small business USD 47,755). These amounts set the fee baseline for any establishment registration or premarket submission occurring after the FY2027 cycle begins.

• Annual establishment registration fee for FY2027: USD 13,785, up from USD 11,423 in FY2026, with no small business reduction in either year.
• 510(k): USD 28,653 standard and USD 7,163 small business in FY2027.
• De Novo request: USD 191,020 standard and USD 47,755 small business in FY2027.
• PMA, PDP, PMR, BLA: USD 636,732 standard and USD 159,183 small business in FY2027.
• Application window: October 1, 2026 through September 30, 2027.

2. Legal basis

The FY2027 figures are drawn from the rate tables on FDA’s MDUFA Fees page, read against the FY2026 Federal Register notice that established the preceding year’s rates and the statutory provision that authorizes annual adjustment. The principal user fee obligation for establishments has applied since October 2007.

FY2026 and FY2027 principal rates compared (in United States dollars):

3. Expert insights

Insight 1: The establishment registration fee is a fixed cost that recurs every year.

Since October 1, 2007, most establishments have been required to pay the establishment registration fee, as stated on FDA’s official page. This is a cost that recurs every fiscal year and is independent of whether the company files any 510(k) or PMA. Even in a fiscal year with no premarket submissions at all, the registration fee remains due. Budgeting that treats the registration fee as an occasional, submission-driven expense misrepresents its nature: it behaves like an annual license to maintain a registered presence in the United States market, and it should sit in the recurring cost line of every United States budget.

Insight 2: The increase between fiscal years acts as a multiplier for companies with multiple establishments.

From FY2026 to FY2027, the annual establishment registration fee rose from USD 11,423 to USD 13,785. For a group with several foreign manufacturing establishments that must register, the increase is multiplied by the number of establishments. This is the component most often underestimated when multi-site companies prepare their United States budgets, because the headline fee change looks modest until it is repeated across every registered site. The correct budgeting unit is therefore not the fee itself but the fee multiplied by the establishment count, reviewed annually.

Insight 3: Small business rates rise in step with the standard rates.

Small business rates are typically 25% of the standard rate. For example, the FY2027 510(k) fee pairs a standard rate of 28,653 with a small business rate of 7,163, and the PMA pairing of 636,732 with 159,183 follows the same proportion. Small business status therefore reduces the proportion of cost but does not eliminate the increase between years. A small business that qualifies for reduced fees should still expect its 510(k), PMA, and De Novo costs to climb alongside the standard schedule, and should retain headroom in the budget for that movement.

Insight 4: Fees are segmented by fiscal year, and submissions that cross the boundary apply at the point of submission.

A company submitting on September 30, 2026 and one submitting on October 1, 2026 are subject to two different rate schedules. Fee planning should therefore be built into project scheduling rather than bolted on afterwards: when a filing date is flexible and the fee difference between fiscal years is material, the fiscal year switch date becomes a scheduling variable in its own right. The applicable schedule should be documented before payment, since the fee owed follows the fiscal year at the time the submission is made.

4. Practical recommendations

The measures below translate the FY2027 rate structure into budgeting and scheduling practice for single- and multi-establishment companies.

• For multi-establishment companies, build a fixed cost model of the number of establishments multiplied by the fiscal year registration fee.
• For projects that cross the fiscal year boundary, factor the fee difference into scheduling decisions: where timing allows and the difference is material, evaluate the fiscal year switch point.
• Update annual budgets around July based on the new Federal Register rate notice for the coming fiscal year.
• Prepare small business budgets at the current small business rates while retaining headroom for increases.
• List the establishment registration fee and premarket submission fees as separate budget lines to avoid mixing them.

5. Verification checklist

Confirm each item below before locking the FY2027 fee budget or scheduling fee-bearing submissions.

• □ The FY2027 application window has been confirmed (2026-10-01 to 2027-09-30).
• □ The annual establishment registration fee has been budgeted at USD 13,785.
• □ Multi-establishment companies have computed the fixed cost by establishment count.
• □ Projects that cross the fiscal year boundary have confirmed their applicable fiscal year.
• □ Small business budgets use the current small business rates and retain headroom for increases.
• □ The establishment registration fee and premarket submission fees are listed as separate budget lines.

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com