FDA U.S. Agent Cost Per Year

Pricing Models (Flat Annual / Tiered / Bundled)

FDA U.S. Agent providers use different pricing models. Understanding these helps you compare quotes effectively:

• paymentsFlat Annual Fee: Single annual payment covering all basic services. Most common model. Predictable cost, easy to budget.
• trending_upTiered Pricing: Different price tiers based on service level (basic, standard, premium). Higher tiers include faster SLAs, inspection support, or regulatory consulting.
• inventory_2Bundled Services: U.S. Agent service bundled with other regulatory services (registration assistance, listing support, consulting). May offer cost savings if you need multiple services.
• account_balanceMulti-Site Discounts: Reduced per-site pricing when using the same provider for multiple establishments. Common for contract manufacturers or multi-facility operations.
• calendar_monthMonthly Billing: Less common, but some providers offer monthly payment options. May cost more annually than annual prepayment.
• receipt_longSetup Fees: One-time setup fee for new clients. Varies by provider. Some include setup in annual fee, others charge separately.

What Drives Cost (Scope, Responsiveness, Inspection Support)

U.S. Agent pricing isn't arbitrary—it reflects what you're actually getting. Understanding the cost drivers helps you evaluate whether you're paying fair value or getting ripped off.

Response time SLAs are a major differentiator. A provider guaranteeing same-day forwarding typically charges $800-1,200/year. One with a 48-hour SLA might charge $400-600/year. The difference matters when FDA sends urgent communications. We've seen companies pay $500/year for an agent who forwards things "when they get around to it," which can mean 3-5 days. For recalls or inspection notices, that delay can be costly. Premium providers offering same-hour forwarding for urgent matters charge $1,200-1,800/year, but they're worth it if timing is critical.

Inspection support adds significant value. Basic agents just forward inspection notices. Premium agents help coordinate dates, understand your time zone constraints, prepare you for what to expect, and even attend pre-inspection calls with FDA. This service typically adds $300-500/year to the base price, but it's invaluable if you're not familiar with FDA inspection processes. We've seen companies save thousands in consultant fees because their U.S. Agent handled inspection coordination.

Team vs. solo operations cost differently. Solo consultants charge $400-700/year but create single points of failure. Team-based providers charge $800-1,500/year but offer redundancy—if one person is unavailable, someone else handles communications. For critical operations, the extra cost is worth it. We've heard horror stories of solo consultants going on vacation and missing critical FDA communications.

Communication channels matter. Email-only forwarding is cheaper ($400-600/year). Providers offering phone/SMS for urgent matters charge more ($800-1,200/year) but provide better responsiveness. 24/7 emergency support adds another $200-400/year premium. If you're dealing with recalls or urgent FDA actions, these channels can be worth the extra cost.

Regulatory expertise commands premium pricing. Providers who understand FDA regulations and can prioritize communications (recognizing what's urgent vs. routine) charge $1,000-1,500/year. Generic mailbox services charge $300-500/year but forward everything with equal urgency, which means you might miss what's actually important. For complex device types or high-risk products, the expertise premium is justified.

Address compliance costs money. Providers with real physical offices (not virtual mailboxes) have overhead costs, so they charge $600-1,200/year. Virtual mailbox services charge $300-500/year but may not meet FDA's "available during business hours" requirement. FDA requires someone who can actually receive mail reliably, not just a forwarding service.

Add-on services increase total cost. Basic forwarding is one price. Adding regulatory consulting, document preparation, or compliance reviews can add $500-2,000/year. Some providers bundle these, others charge à la carte. Understand what you're paying for—a $1,500/year provider might include consulting that a $600/year provider charges separately.