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FDA Small Business Fee Waivers! Full Application Guide for FY2026

Time：2026-07-15 11:56:59

For medical device companies targeting the U.S. market, user fees for FDA premarket submissions constitute a major cost of overseas expansion. The Small Business Determination (SBD) Program launched by CDRH is a core official policy offering reduced or fully waived filing fees for enterprises meeting revenue thresholds.

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https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program

一、Overview of the SBD Program

SBD (Small Business Determination) is a qualification program established by the FDA under the MDUFA Act. Companies may submit an SBR (Small Business Request) application; once approved, they qualify for discounted user fees on medical device regulatory submissions.

The FDA does NOT define small businesses by headcount. The sole eligibility criterion is the combined gross revenue of the applicant and all its affiliated entities in the most recent tax year. Three revenue tiers apply, each with distinct benefits:

（一）Combined annual gross revenue ≤ $100 million

Qualifies for reduced fees on most CDRH premarket submissions, including:

510(k) Premarket Notifications
De Novo Classification Requests
Premarket Approval (PMA), Biologics License Application (BLA), Product Development Protocol (PDP), Premarket Report (PMR)
PMA/BLA Supplements, Annual PMA Reports
30-Day Notices
513(g) Information Requests

（二）Combined annual gross revenue ≤ $30 million

Covers all Tier 1 benefits, plus a full fee waiver for the company’s first-ever major submission. The "first submission" refers to the initial PMA (including modular PMA), BLA, PDP or PMR received by the FDA for the applicant or its affiliates.

（三）Combined annual gross revenue ≤ $1 million

May apply for a full facility registration fee waiver if both additional requirements are met:

The company can demonstrate that paying registration fees would create severe financial hardship (e.g., ongoing bankruptcy proceedings);
The company has a record of fully paying FDA registration fees in prior fiscal years.

Important Note：Standard facility registration fees are not eligible for tiered small-business discounts. Full waivers are only available to enterprises meeting Tier 3 criteria above.

二、Two Key Policy Updates for FY2026

New adjustments apply to applications for Fiscal Year 2026 (October 1, 2025 – September 30, 2026) and subsequent fiscal years:

（一）Fully Online Submission Mandate

Effective November 1, 2024, all SBD applications (SBRs) must be filed electronically via the CDRH Portal. Paper submissions are no longer accepted. Enterprises may upload documents, respond to FDA inquiries and track review status entirely through the portal. Contact Wiselink for detailed filing workflows.

（二）Unified Application Form

Starting August 1, 2025, all SBR applications use Form 3602N exclusively. It replaces the old split forms: Form 3602 (U.S.-domestic firms) and Form 3602A (foreign-headquartered firms). Both U.S. and overseas applicants now share the same single form.

三、Critical SBD Application Risk Avoidance Guide

（一）Strictly Adhere to Application Timelines

The FDA opens the SBD application window for the next fiscal year every August 1, with acceptance spanning the full fiscal year. For FY2026, regular SBR submissions are accepted from August 1, 2025 to September 30, 2026.Registration fee waiver requests have an earlier deadline: all filings must be submitted within one month of the new fiscal year launch. The FY2026 registration fee waiver cutoff date is October 31, 2025. Companies seeking this waiver must prepare materials well in advance.

（二）Qualifications Are Entity-Specific & Non-Transferable

SBD approval is exclusive to the applicant company and cannot be transferred, shared or assigned to third parties. After mergers, acquisitions or major equity changes, the acquiring entity cannot inherit the seller’s SBD status and must submit a brand-new independent SBR application.Additionally, third-party consulting firms cannot extend their own small-business credentials to client companies for filing purposes. For discounted fees to apply, the filing entity, fee payer and SBD approved entity must be identical in all records. Any mismatch disqualifies the discount.

（三） File SBD Approval Before Submitting Fee-Bearing Premarket Applications

Filing order directly determines fee amounts and is the most commonly overlooked compliance pitfall. If a company submits a chargeable application (510(k), De Novo, PMA, etc.) before receiving an official SBD approval number, the FDA will charge the full standard fee. Even if the firm later obtains SBD qualification, the FDA will not refund the difference between standard and small-business reduced fees.Best practice: Secure formal SBD determination documentation first, then submit all regulatory filings subject to user fees to lock in discounted pricing.

（四）SBD Credentials Expire Annually with No Auto-Renewal

SBD status never lasts indefinitely and does not automatically roll over to the next fiscal year. All approvals expire on September 30 of the corresponding fiscal year. Companies must resubmit and reapprove a new SBR each year to retain fee reduction benefits.

（五）Document Requirements for U.S.-Based Applicants

U.S. domestic firms must provide complete federal income tax returns from the most recent tax year; applications without valid tax filings will not enter review.

Newly established companies operating less than 12 months may submit partial-year tax records supplemented with business formation certificates.
Sole proprietors may file personal IRS Form 1040 with Schedule C attached to verify gross revenue.

（六）Alternative Revenue Proof for Overseas Companies

Foreign enterprises located in jurisdictions without official tax certification bodies do not need to abandon applications entirely. They may submit audited year-end financial statements, shareholder reports and other credible revenue evidence to the FDA. Such materials will undergo case-by-case review for compliance with small-business revenue thresholds.

四、Frequently Asked Misconceptions Resolved

Q：Am I eligible for a full waiver of annual facility registration fees as a small business?

A：若您同时满足以下全部三项条件，则有资格申请减免注册费：企业(包括其关联企业)在最近一个纳税年度的总收入或销售额不超过 100 万美元，你可以证明缴纳注册费将构成小型企业指导文件所定义的经济困难，并且企业能提供证明，表明曾在上一财年缴纳过注册费。就注册费减免事宜而言，对于已主动注册的企业，FDA 的标准注册申请(SBR)接收截止日期为 10 月31 日。Full registration fee waivers require all three criteria to be satisfied:

Combined gross revenue of the company and all affiliates ≤ $1 million in the prior tax year;
Documentation proving registration fees would create economic hardship as defined in FDA small-business guidance;
Proof of complete registration fee payments in the previous fiscal year.

For registration fee waiver requests, the standard SBR filing deadline is October 31 each fiscal year for registered facilities.

Q：What happens if I pay MDUFA user fees before receiving FDA small-business determination?

A：Any premarket submission filed prior to SBD approval incurs full standard fees. Subsequent SBD approval does not trigger a refund of the price gap between standard and discounted small-business fees. To qualify for reduced rates, wait for an official SBD determination number before submitting any fee-bearing applications.

Q：Does small-business determination status expire?

A：Yes. All SBD approvals expire on September 30 of the fiscal year they are granted. A new MDUFA small-business application must be submitted and approved annually to maintain eligibility.

五、Compliance Action Recommendations for Enterprises

Calculate combined gross revenue across the parent company and all affiliated entities to accurately assess eligibility and match applicable discount tiers;
Entities seeking FY2026 small-business fee benefits must complete full SBR filings before the August 1 deadline—no late submissions will be accepted;
Companies planning to submit 510(k)/De Novo/PMA filings between late 2026 and FY2027 should prepare tax and corporate documentation in advance, and file FY2027 SBD applications immediately after the August 1 portal launch;
Map all domestic and overseas affiliated entities, compile unified tax and revenue supporting documents to avoid review suspensions and delay-inducing RFEs (Requests for Evidence).

五、Closing Remarks

As FDA medical device user fees continue rising year over year, the SBD small-business program is the most direct, official cost-reduction policy for Chinese medical device manufacturers expanding into the U.S. market. SBR filing windows are fixed and narrow, and annual renewal is mandatory—missing the deadline means paying full standard regulatory fees for all submissions. Reach out to Wiselink for personalized consulting support if you require further clarification.

Brazil boasts Latin America’s largest and most sophisticated medical device regulatory market, making it a core expansion target for domestic medtech firms. To celebrate Wiselink’s 6th anniversary, we offer a 20% discount on consulting fees for all risk-class medical device products for Brazil, valid June 18 – July 18. New and returning clients are welcome to inquire.

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