Are You Aloof About MDUFA? Planning for Medical Device User Fees in FY 2027

Part 2 of the “Are You Aloof About OMUFA, MDUFA, and GDUFA?” series.

This is the second installment in a three-part series on FDA user fee programs. Part 1 covered OMUFA, and Part 3 will address GDUFA.

MDUFA Is More Than Just a Submission Fee

When companies think about FDA medical device fees, they often focus on the submission: “How much will our 510(k), De Novo, or PMA cost?”

But MDUFA includes more than application fees. Most device establishments must also pay an annual registration fee, meaning total exposure may include:

• Annual establishment registration fees
• Premarket submission fees (510(k), De Novo, PMA, etc.)
• Supplement and amendment fees
• Certain periodic reporting fees for Class III devices

MDUFA V runs through September 30, 2027, with MDUFA VI expected to follow in FY 2028.

FY 2027 Establishment Registration Fee

$13,785 per establishment (up from $11,423 in FY 2026)

This fee is separate from any submission fee and applies to most FDA-registered device establishments. Companies with multiple facilities may face significantly higher total costs than expected.

FY 2027 MDUFA Application Fees (Selected)

FY 2027 runs from October 1, 2026, through September 30, 2027.

Example total costs (one establishment + one submission):

These figures exclude development, clinical, and regulatory preparation costs.

510(k) Fee Exceptions

Most 510(k)s are fee-liable, but submissions routed through an FDA-accredited third-party review program are exempt from FDA’s 510(k) fee (though third-party reviewers may charge separately).

Small-Business Status Can Reduce Fees Dramatically

If qualified through FDA’s Small Business Determination program, companies may pay significantly reduced fees. For example:

However, eligibility is not automatic. Companies should plan early for:

• Application preparation time
• Affiliate and ownership impacts
• Required documentation
• FDA approval timing before submission

Waiting too long may force payment of full fees.

Registration Fee Waivers Are Limited

The establishment registration fee is not automatically reduced for small businesses. A waiver may be granted only if:

• The company qualifies as a small business, and
• FDA determines financial hardship

Companies should budget for the full fee unless a waiver is formally approved.

Common MDUFA Planning Mistakes

• Budgeting only for submission fees
• Assuming small-business status applies automatically
• Choosing the regulatory pathway too late
• Relying on outdated or inconsistent establishment data

FY 2027 MDUFA Readiness Checklist

Before October 1, 2026, companies should:

1. Identify all fee-liable establishments
2. Confirm registration responsibility
3. Map planned submissions and pathways
4. Evaluate small-business eligibility early
5. Complete determinations before submission
6. Budget for full fees unless reduced rates are confirmed
7. Reconcile FDA registration and listing data
8. Track payments and FDA correspondence

Key Takeaway: Plan Before the Submission

MDUFA costs are driven by both establishments and submissions, and surprises often come from overlooked registration fees or late pathway decisions.

Early alignment between regulatory, finance, and product teams helps avoid last-minute budget gaps and submission delays.

Reduce uncertainty in FDA user fee planning.

MDUFA planning should begin long before a submission is ready. Companies that align regulatory strategy with financial planning are better positioned to control costs and avoid delays.

Contact LexisNexis Life Sciences to learn how integrated establishment, product, and submission data can help your team forecast MDUFA costs more accurately and avoid last-minute surprises.

Next in the series: Part 3 explores GDUFA and the complexity of generic drug user fees across applications, affiliates, and facilities.

Editorial note: Fee figures are current as of August 13, 2026. Companies should confirm current FDA requirements before making payment or submission decisions.