FDA Registration Fees 2026: Complete Cost Breakdown

FY2026 FDA Fee Overview

Each fiscal year, FDA publishes updated user fee schedules under Congressional reauthorization acts. These fees fund FDA's review and inspection activities. For FY2026 (October 1, 2025 through September 30, 2026), fees are governed by MDUFA V for devices, PDUFA VII for drugs, and GDUFA III for generic drugs.

Understanding which fees apply to your business is essential for budgeting. Some categories—food and cosmetics—have no FDA user fees at all, while drug and device fees can be substantial.

It is critical to distinguish between FDA user fees (paid directly to the agency), service provider fees (paid to companies like Assurentry for registration assistance), and compliance costs (internal investments in quality systems, testing, and documentation).

Device Fees (MDUFA V)

Under the Medical Device User Fee Amendments V (reauthorized in 2022, codified at 21 USC 379j), device fees for FY2026 were published in the Federal Register in August 2025. Key fee amounts:

Device establishment registration fees are paid annually during the October–December registration window. Unlike drugs, device companies pay a single establishment fee regardless of how many devices they list. Source: 21 CFR Part 807, FDA MDUFA V fee schedule (87 FR 45938).

Drug Fees (PDUFA VII)

The Prescription Drug User Fee Act VII, reauthorized under the FDA Reauthorization Act of 2022 (Public Law 117-180), sets the highest fees in all of FDA regulation. For FY2026:

Annual product fees for FY2026 are approximately $130,566 per approved NDA/BLA. These fees are invoiced by FDA each year and are not optional. Failure to pay results in the application being considered incomplete. Source: FDA FY2026 PDUFA fee revenue amounts (21 USC 379h).

Food & Cosmetics — Both Free from FDA

While both food and cosmetics registrations are free from FDA, the compliance effort is real. Food facilities must maintain FSMA-compliant food safety plans (21 CFR Part 117), and cosmetics companies must comply with MoCRA safety substantiation and adverse event reporting requirements.

Small Business Reductions

FDA offers small business fee reductions for devices and drugs, but eligibility criteria differ significantly:

Medical Devices (MDUFA V)

Small businesses with gross receipts or sales of $100 million or less receive a 75% reduction on premarket submission fees (510(k), De Novo, PMA). The establishment registration fee is not reduced. Qualification must be certified each fiscal year via FDA's online system before submitting. See 21 USC 379j(d)(2)(B).

Prescription Drugs (PDUFA VII)

First-time applicants with fewer than 500 employees may qualify for application fee waivers. Ongoing small business applicants with annual revenue below the threshold set by FDA (historically around $40 million from PDUFA products) may receive reduced application fees. Establishment and product fees are generally not reduced for small drug companies. See 21 USC 379h(d).

Generic Drugs (GDUFA III)

Small generic drug companies may qualify for reduced ANDA fees. The criteria are based on the number of approved ANDAs the company holds. Source: 21 USC 379j-42.

Assurentry Service Fees vs FDA Fees

Assurentry's service fees are separate from and in addition to any FDA user fees. Here is how they compare:

Assurentry's service fees cover guided registration, compliance dashboards, renewal reminders, and expert support. FDA fees are paid directly to the agency. Our pricing page has the latest rates.

How to Budget for FDA Compliance

Building an accurate FDA compliance budget requires accounting for all cost layers:

• Year 1 startup costs: Registration service fees, initial FDA user fees (if applicable), quality system setup, labeling design, and testing
• Recurring annual costs: FDA establishment fees (drugs/devices), US Agent fees (foreign facilities), compliance monitoring subscriptions, and renewal processing
• Variable costs: Premarket review fees (510(k), PMA, NDA), labeling updates, adverse event management, and audit preparation
• Contingency: Budget 10–15% for unexpected compliance needs such as FDA information requests, label changes, or regulatory updates