FDA Registration Costs in 2026: Complete Breakdown

FDA User Fees Overview

FDA charges user fees to fund its review and inspection programs. These fees are authorized by Congress and adjusted annually. Understanding which fees apply to your business is the first step in budgeting for FDA compliance.

It is important to distinguish between three types of costs:

• FDA user fees: Mandatory fees paid directly to FDA for registration, listing, and application review
• Service provider fees: Fees paid to companies like Assurentry for help navigating the registration process
• Compliance costs: Internal costs for documentation, labeling, testing, and ongoing compliance activities

For the most current fee schedule, see our pricing page which is updated whenever FDA publishes new fee amounts.

Food Facility Registration Costs

While the FDA registration itself is free, the process involves navigating the FDA Industry Systems (FIS) portal, obtaining a DUNS number, and ensuring your registration details are accurate. Errors can lead to delays at the port. Biennial renewal is required for food facilities during even-numbered years.

Foreign food facilities also need a US Agent, which is a separate annual cost. Assurentry offers US Agent services at $399/year, which includes the communication link, compliance dashboard, and renewal reminders.

Drug Establishment Fees (PDUFA)

Drug establishment fees are the most expensive category of FDA registration costs. The Prescription Drug User Fee Act (PDUFA) funds FDA's drug review programs. For FY2026, key fees include:

Small businesses may qualify for fee waivers or reductions. FDA provides a small business qualification process for companies with less than $40 million in annual revenue from PDUFA products. Assurentry helps drug establishments with registration and listing for $349/year, separate from PDUFA fees paid directly to FDA.

Medical Device Fees (MDUFA)

The Medical Device User Fee Amendments (MDUFA) fund FDA's device review program. Device fees are more moderate than drug fees but still represent a significant business expense:

Annual device establishment registration with FDA is free, but the process requires detailed device listing information. Assurentry's medical device registration service costs $449/year and includes establishment registration, device listing, and compliance tracking.

Cosmetics Registration Costs

Under MoCRA, cosmetics facility registration and product listing are free from FDA. There are no FDA user fees for cosmetics at this time. However, the compliance effort is significant:

While registration is free, companies must invest in safety substantiation, labeling compliance, adverse event reporting systems, and good manufacturing practices. These operational costs can be significant, especially for companies new to FDA regulation.

Assurentry vs. Competitors vs. DIY

When budgeting for FDA registration, you have three options:

Assurentry consistently offers the best value by combining transparent flat-rate pricing with technology-driven workflows and expert oversight. See how we compare to specific competitors on our comparison page.

Hidden Costs to Watch For

Beyond the obvious fees, several hidden costs catch businesses off guard:

• Expedited processing fees: Some providers charge premium rates for faster turnaround. At Assurentry, standard processing is already fast.
• Renewal fees: Food facilities must renew biennially; drug and device establishments annually. Budget for these recurring costs.
• Amendment fees: Changes to your registration (new products, address changes) may incur additional charges with some providers.
• US Agent fees: Foreign facilities must separately budget for US Agent services, which are required for registration.
• Compliance maintenance: Ongoing costs for labeling reviews, adverse event reporting, and regulatory monitoring.