Small Business Determination and User Fee Reductions

1. Key takeaways

Small Business Determination (SBD) is assessed under the MDUFA V terms. According to the rules set out in 90 FR 35895, a small business is an enterprise whose total revenue, together with that of its affiliates, does not exceed USD 100,000,000. An enterprise whose total revenue does not exceed USD 30,000,000 may additionally receive a fee waiver for its first PMA. The two thresholds serve different purposes, and both are measured on the combined revenue of the enterprise and its affiliates rather than on the applying entity alone.

• Small business eligibility: total revenue of the enterprise and its affiliates not exceeding USD 100,000,000.
• First PMA waiver: available where total revenue does not exceed USD 30,000,000.
• Small business rates apply to review-type fees, not to the annual establishment registration fee.
• Governing documents: MDUFA V terms in 90 FR 35895 and the FD&C Act Section 738A authorization.

2. Legal basis

The small business framework derives from the MDUFA V terms codified in the annual user fee notice and from the statutory user fee authorization, which includes the authority for small business reductions. The sources below are where the thresholds and the small business rate column can be verified.

3. Expert insights

Insight 1: The measuring standard is total revenue, and it includes affiliates.

Under the rules in 90 FR 35895, the determination is made on the total revenue of the enterprise and its affiliates. For companies with complex group structures, this means the domestic and foreign affiliate entities must be consolidated into the calculation; the revenue of the applying entity alone cannot be used. A group in which each subsidiary sits below the threshold on a standalone basis may still exceed the threshold on a consolidated basis, and the reverse can also occur. Getting the consolidation perimeter right, and documenting it, is therefore the first substantive step in any small business application rather than an afterthought, and an application built on the wrong revenue perimeter will fail regardless of the underlying numbers.

Insight 2: USD 100,000,000 is the eligibility threshold and USD 30,000,000 is the PMA waiver threshold.

The two figures do different work. Below USD 100,000,000 in total revenue, the enterprise qualifies as a small business and may use the small business column of the fee schedule. Below USD 30,000,000, the enterprise’s first PMA may receive a fee waiver. The first threshold determines whether the reduced rates are available at all; the second is an additional, narrower benefit attached specifically to the first PMA. Companies should track both thresholds separately, because a growing enterprise can lose the PMA waiver years before it loses small business eligibility, and the loss of each threshold has different budget consequences that should be reviewed with the finance function on a defined schedule.

Insight 3: Small business rates are typically 25% of the standard rates.

Taking FY2027 figures as an example, the 510(k) fee is USD 28,653 at the standard rate and USD 7,163 at the small business rate, while the PMA fee is USD 636,732 standard against USD 159,183 small business. The proportion is approximately 25%. This proportionality is useful for planning: once eligibility is secured, the small business column scales the review fees consistently across submission types, and the savings grow in absolute terms as the underlying fee grows, which is most visible on the PMA scale fees.

Insight 4: The annual establishment registration fee does not enjoy the small business reduction.

This is the most common budgeting mistake connected to small business status. Small business qualification applies to the premarket submission-type fees; it does not apply to the annual establishment registration fee, which stands at USD 11,423 for FY2026 and USD 13,785 for FY2027 at the standard rate. A small business that budgets its registration fees at a discounted rate will systematically understate its recurring cost. The correct model is: reduced rates for review fees, full standard rate for every registered establishment every year, with the split documented explicitly in the budget workbook.

4. Practical recommendations

The measures below sequence the small business determination correctly and keep the resulting budget accurate.

• Before applying, consolidate the total revenue of the enterprise and its affiliates and confirm it is below USD 100,000,000.
• Where the PMA is the first one and total revenue is at or below USD 30,000,000, apply for the PMA waiver in the same step.
• In the budget, separate the items eligible for reduction from the items not eligible, with the key point being that the annual establishment registration fee is not reduced.
• Complete the qualification determination before the first submission; the qualification is not retroactive to fees already paid.
• Align the affiliate revenue measuring standard with the finance department to avoid inconsistent calibers blocking the application.

5. Verification checklist

Confirm each item below before relying on small business status in a submission or a budget.

• □ Total revenue of the enterprise and its affiliates has been consolidated and confirmed at or below USD 100,000,000.
• □ If the PMA is the first one, it has been confirmed whether total revenue is at or below USD 30,000,000.
• □ The qualification determination was completed before the first submission.
• □ The budget distinguishes reducible items from non-reducible items.
• □ The annual establishment registration fee has been budgeted at the standard rate, without reduction.
• □ The affiliate revenue caliber has been aligned with the finance department.

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