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Medical Device Regulatory News and Industry Insights
The US FDA has officially released the revised FDA medical device user fee schedule for Fiscal Year (FY) 2027. Authorized under the Medical Device User Fee Amendments (MDUFA V), these updated rates apply to medical device premarket submissions, application supplements, and annual establishment registrations submitted from October 1, 2026, through September 30, 2027.
These fees are a critical component of the FDA’s regulatory framework, providing the agency with the resources needed to increase review efficiency, meet strict performance goals, and reduce the time it takes to bring safe, effective medical devices to the U.S. market.
FY 2026 vs. FY 2027 MDUFA Fee Comparison
To help medical device manufacturers plan their regulatory budgets, below is a direct comparison of the standard and small business user fees for the current FY 2026 versus the upcoming FY 2027 rates.
Application / Fee Type | FY 2026 Standard | FY 2026 Small Business | FY 2027 Standard | FY 2027 Small Business |
Annual Establishment Registration | $11,423 | Waiver Possible | $13,785 | Waiver Possible |
510(k) Premarket Notification | $26,067 | $6,517 | $28,653 | $7,163 |
513(g) Request for Information | $7,820 | $3,910 | $8,596 | $4,298 |
PMA, PDP, PMR, BLA | $579,272 | $144,818 | $636,732 | $159,183 |
De Novo Classification Request | $173,782 | $43,446 | $191,020 | $47,755 |
Panel-track Supplement | $463,418 | $115,855 | $509,386 | $127,347 |
180-Day Supplement | $86,891 | $21,723 | $95,510 | $23,878 |
Real-Time Supplement | $40,549 | $10,137 | $44,571 | $11,143 |
BLA Efficacy Supplement | $579,272 | $144,818 | $636,732 | $159,183 |
30-Day Notice | $9,268 | $4,634 | $10,188 | $5,094 |
Annual Fee (Class III Periodic Reporting) | $20,275 | $5,069 | $22,286 | $5,572 |
(Note: All types of 510(k)s—Traditional, Abbreviated, and Special—are subject to the medical device user fee. However, there is no fee for 510(k)s submitted on behalf of an FDA-accredited third-party reviewer.)
Qualifying for the Small Business Fee
For both FY 2026 and FY 2027, companies qualified by the Center for Devices and Radiological Health (CDRH) as a small business benefit from significantly reduced application rates. Additionally, the FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to certain small businesses that can demonstrate financial hardship.
Also Read: US FDA Establishment Registration Renewal for Medical Devices
Background and Legislation
Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). The program has been successfully renewed multiple times:
- 2007: MDUFA II (FDA Amendments Act)
- 2012: MDUFA III (FDA Safety and Innovation Act)
- 2017: MDUFA IV (FDA Reauthorization Act)
- 2022: MDUFA V (FDA User Fee Reauthorization Act)
MDUFA V is currently active until September 30, 2027. By paying an FDA medical device user fee, manufacturers directly fund the FDA’s ability to hire expert reviewers, upgrade IT systems, and ensure a predictable, timely path to U.S. market approval. For more details, official guidelines, and payment procedures, manufacturers can consult the official FDA MDUFA User Fee Program portal.
Reduce Submission Delays with Expert FDA Guidance.
How Operon Strategist Can Help
With the FDA’s new FY 2027 MDUFA fees coming into effect, strategic regulatory planning is crucial to prevent costly submission delays, rejections, or unnecessary fee expenditures. Operon Strategist provides end-to-end regulatory consulting to help manufacturers navigate FDA requirements smoothly and achieve rapid market access.
Our key services include:
- US FDA (510(k), QMSR, & Registration): Comprehensive regulatory consulting for 510(k) premarket notifications, De Novo classifications, and facility registrations to ensure your submissions are accepted right the first time.
- FDA User Fee Optimization: We guide eligible manufacturers through the Small Business Determination (SBD) process, helping you qualify for drastically reduced MDUFA user fees and lower your overall regulatory submission costs.
- Quality Management System (QMS): We help establish, audit, and maintain fully compliant QMS frameworks tailored to the FDA’s Quality Management System Regulation (QMSR).
- Global Product Registration: Once US FDA clearance is secured, our team seamlessly manages your market expansion strategies across other international regulatory landscapes.
Our team works closely with medical device manufacturers, startups, and digital health innovators to simplify compliance, optimize regulatory budgets, and ensure the successful commercialization of your medical devices.
Also Read: Navigating Access to USFDA 510(k) Database (Step-by-Step).
Publisher | Medical Device Regulatory News and Industry Insights
The Operon Strategist Editorial Team publishes news, updates, and insights on medical device regulations, regulatory policy changes, and global healthcare industry developments. The team covers key regulatory frameworks, including CDSCO, US FDA, EU MDR, ISO 13485, and international market access requirements, helping medical device manufacturers and healthcare businesses stay informed about evolving regulatory expectations.
