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FDA Medical Device User Fees Rise Across the Board – Master Timelines to Control Budgets

Time：2026-08-03 11:01:02

The U.S. FDA has updated the latest fee schedule under the Medical Device User Fee Amendments (MDUFA), setting out full rates for all device submissions and establishment registrations for Fiscal Year (FY) 2027 (October 1, 2026 – September 30, 2027). The current MDUFA V will expire on September 30, 2027, while the new MDUFA VI framework (covering FY 2028–2032) has reached a tentative agreement, which will bring further adjustments to user fees in the coming years.

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https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees

一、Foundational Framework: MDUFA

MDUFA stands for the Medical Device User Fee Amendments, the core funding legislation governing FDA medical device review operations, renewed every five years.

Origins：The Medical Device User Fee and Modernization Act (MDUFMA) first established the device user fee system in 2002. Subsequent iterations include MDUFA II through V, with MDUFA V currently in force (October 1, 2022 – September 30, 2027).

Fiscal Year Cycle：The FDA updates fee rates every October 1st each fiscal year. After the end of FY 2027, regulations will shift to the new MDUFA VI regime.FY 2027 marks the final fiscal year under MDUFA V. On July 8, the FDA released a draft commitment letter for MDUFA VI (2028–2032). A public meeting will be held on August 5 to discuss the five-year fee framework for the next term, which will set the new fee structure effective FY 2028 with significant uncertainties over upcoming pricing changes.

二、Across-the-Board Fee Hikes for FY 2027 (Oct 1, 2026 – Sep 30, 2027)

Built-in inflation adjustments are mandated under MDUFA V, triggering uniform price increases for all fee categories in FY 2027. Full rate details are listed below:

（一）Annual Establishment Registration Fees

FY2026（2025.10.1–2026.9.30）：$11,423 per year

FY2027（2026.10.1–2027.9.30）：$13,785 per year

Increase vs FY2026: $2,362, representing a ~20.7% year-over-year rise

（二）Submission Fee Comparison: FY 2026 vs FY 2027 – Standard Rates

Key cost hike takeaways：Standard 510(k) submissions for Class I devices see a fee increase of $2,586.A single Premarket Approval (PMA) master submission for Class III devices jumps by $57,460, creating substantial cost pressure for manufacturers of high-value implantable and active implantable devices.Annual establishment registration fees have also risen sharply, driving up recurring fixed compliance costs for enterprises launching multiple product lines into the U.S. market year-round.

（三）Small Business Exemption (SBD) Submission Fee Comparison: FY 2026 vs FY 2027

三、Core Cost-Saving Tool: Small Business Determination (SBD)

（一）Three Tiered Revenue Thresholds & Corresponding Discount Benefits

General Discount Tier (Total corporate revenue ≤ $100 million, including all affiliated entities)：Applies to all submission types listed above, cutting standard submission fees down to 25% of the base rate; 513(g) fees are halved. The vast majority of Chinese startup device firms and niche SMEs qualify for this tier.

Full Waiver for First PMA Submission (Total corporate revenue ≤ $30 million)：Enterprises submitting their first PMA/BLA/PDP application qualify for a complete waiver of submission fees, a one-time benefit ideal for startups developing innovative Class III medical devices.

Registration Fee Exemption Tier (Total corporate revenue ≤ $1 million)：Upon securing SBD status and submitting proof of financial hardship, companies may apply for waivers of annual establishment registration fees (initial registration fees excluded).

（二）Practical Guidelines for Chinese Manufacturers Applying for SBD

Required Form：FDA Form 3602A, Application for Small Business Determination for Foreign Establishments

Supporting Documentation：Stamped revenue certification issued by domestic tax authorities for the most recent fiscal year; total revenue must consolidate all parent, subsidiary and affiliated legal entities.

Validity Window：SBD certification is only valid for a single fiscal year. Applications for the upcoming fiscal year open every August and must be resubmitted annually.

Eligibility Scope：No U.S.-domestic entity restrictions; foreign medical device manufacturers enjoy equal access to all discount benefits.

四、Operational Recommendations for Chinese Medical Device Exporters

Tiered Budget Planning：Class I device manufacturers should prioritize SBD certification to drastically reduce 510(k) filing costs. Companies submitting De Novo Class II applications or Class III PMAs must budget for six-figure single-submission expenses, alongside recurring annual establishment registration fees and Class III annual reporting fees.

Early SBD Certification Preparation：Application portals for the next fiscal year open every August. Prepare tax revenue documentation well in advance to avoid paying the full undiscounted 75% surcharge on filing fees due to missing valid SBD status at submission.

Fiscal Year Deadline Management：Any submission filed in Q4 2026 will fall under the higher FY 2027 fee schedule. Strategically align filing timelines to balance speed-to-market and compliance expenditure.

Multi-Site Establishment Planning：Each U.S.-registered manufacturing or distribution facility requires a separate annual registration fee. Map all global production sites in advance to calculate full-year fixed compliance overheads.

五、Closing Remarks

FDA medical device user fees directly determine the commercialization costs of Chinese medical device companies entering the U.S. market. Universal fee increases for FY 2027 are confirmed. Mastering the full rate schedule and securing SBD small business discounts in advance is critical to controlling overseas compliance budgets. For further inquiries, please contact Wiselink.

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