First-Time Exporter? We'll Guide You Through FDA Compliance
Exporting to the US for the first time is daunting. FDA requirements vary by product type, and mistakes can mean shipments held at port, products refused entry, or costly delays. We make it simple.
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The Challenge of Exporting to the US
The United States is the world's largest consumer market, but accessing it requires navigating a complex regulatory landscape. The FDA regulates food, drugs, medical devices, cosmetics, and dietary supplements, and each category has its own set of registration, labeling, and compliance requirements.
For first-time exporters, the process can feel overwhelming. Which regulations apply to your products? Do you need a US Agent? What labeling changes are required? When must you file Prior Notice? These are questions that many exporters only discover after their first shipment is already held at port.
The cost of getting it wrong is significant. A single detained shipment can cost thousands in storage fees, re-export charges, and lost business. Repeat violations can result in Import Alerts that make future shipments even harder to clear. Starting with proper compliance is always less expensive than fixing problems after the fact.
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Your Step-by-Step Path to FDA Compliance
Follow this proven process to get your products into the US market. Each step builds on the previous one, and skipping steps leads to problems at port.
Determine Your FDA Product Classification
FDA categorizes products into food, drugs, medical devices, cosmetics, and dietary supplements. Your classification determines which regulations apply, what registrations you need, and what labeling requirements you must meet.
Register Your Facility with FDA
All foreign facilities that manufacture, process, pack, or hold FDA-regulated products must register with the FDA before exporting to the US. Registration requirements and timelines vary by product type.
Designate a US Agent
Every foreign facility registered with FDA must have a US-based agent who can communicate with FDA on your behalf. Your US Agent must be physically located in the United States and available 24/7.
Prepare US Market Labeling
US labeling requirements are often different from your home country. Labels must include specific information in English, follow FDA formatting rules, and comply with ingredient declaration requirements.
File Prior Notice (Food Shipments)
For food products, FDA requires advance notice before your shipment arrives at a US port. Timing depends on transportation mode, ranging from 2 to 15 hours before arrival.
Ensure FSVP Compliance
Your US importer must have a Foreign Supplier Verification Program in place. This means they must evaluate your facility and verify you meet US food safety standards before importing your products.
Maintain Ongoing Compliance and Renewals
FDA compliance is not one-and-done. Food facilities renew biennially, drug and device establishments annually. Your US Agent designation must remain active, and regulations may change.
Not sure which steps apply to you?
Our free compliance calculator analyzes your products and tells you exactly what you need.
Check My RequirementsCommon First-Timer Mistakes
These are the errors we see most often from first-time exporters. Each one can cost you thousands in delays and fees.
Not registering before first shipment
Shipments from unregistered facilities are automatically detained at port. FDA will refuse entry, and you bear all storage and re-export costs.
Using incorrect product codes
Wrong product codes trigger FDA scrutiny and can flag your shipment for examination. This causes delays of days to weeks and may result in refusal.
Non-compliant labeling
Products with labels that do not meet US requirements are refused entry. Relabeling at port is expensive and may not be permitted for all product types.
Missing Prior Notice deadlines
Food arriving without adequate Prior Notice will be held at port. You cannot file retroactively. The shipment may be refused and returned at your expense.
Not understanding FSVP obligations
If your US importer lacks a compliant FSVP, FDA can hold your products and issue warning letters. This affects all future shipments from your facility.
How Assurentry Helps First-Time Exporters
We've helped over 2,800 companies navigate their first US export. Our platform guides you through every step, handles the paperwork, and ensures nothing falls through the cracks.
Unlike generic consulting firms, Assurentry combines expert oversight with an automated compliance platform. You get a dashboard that tracks your registration status, upcoming deadlines, and compliance score in real time.
Compliance Assessment
We analyze your products and determine exactly which FDA requirements apply to your specific situation.
Guided Registration
Step-by-step registration process with expert review. We handle the FDA paperwork so you can focus on your business.
US Agent Services
24/7 US Agent designation required for all foreign facilities. We handle all FDA communications on your behalf.
$399/yr
Labeling Review
Our experts review your product labels against US requirements and identify changes needed before shipping.
Ongoing Compliance Monitoring
Automated renewal reminders, regulatory change alerts, and compliance score tracking for your facility.
Prior Notice Filing
We prepare and file Prior Notice for your food shipments, ensuring correct timing and complete information.
Starter Pricing for First-Time Exporters
Transparent pricing with no hidden fees. Most first-time exporters start with our US Agent + Registration bundle.
Frequently Asked Questions
Answers to the questions we hear most from first-time exporters.
How long does it take to get FDA registered?
FDA facility registration is typically processed within 1-5 business days for food facilities and drug establishments. Medical device establishments may take longer due to additional listing requirements. We recommend starting at least 30 days before your planned first shipment to allow time for registration, US Agent designation, and any corrections needed.
Do I need a US Agent if I sell through a distributor?
Yes. The US Agent requirement applies to the foreign facility, not the sales arrangement. Even if you sell through a US distributor, your manufacturing or processing facility must be registered with FDA and have a designated US Agent. The US Agent serves as FDA's point of contact for your facility.
What happens if my shipment is held at the port?
If your shipment is detained, FDA will issue a Notice of Detention explaining the reason. You or your importer can request a hearing within 10 days. Options include exporting the goods, destroying them, or reconditioning them if possible. Having a US Agent helps because they can communicate directly with FDA to resolve issues faster.
How much does it cost to comply with FDA requirements?
FDA registration itself is free. Costs include US Agent services ($399/year with Assurentry), facility registration assistance ($199-$449 depending on product type), and optional services like labeling review and FSVP development. Total first-year costs typically range from $600 to $1,500, far less than the cost of a single detained shipment.
Do I need to register for each product I export?
You register your facility, not individual products. However, you must list the products you manufacture at that facility. For drugs and devices, product listing is required in addition to establishment registration. For food, you need to identify the general food product categories handled at your facility.
Can I export to the US while my registration is pending?
No. Your facility registration must be active and confirmed by FDA before you ship products to the US. Shipments from unregistered facilities will be automatically detained and refused entry. We recommend completing registration at least 2 weeks before your first shipment.
Related Resources
FDA Food Facility Registration Guide
Everything you need to know about registering your food facility with the FDA.
US Agent Requirements Guide
Understand who needs a US Agent, what they do, and how to designate one.
Compliance Calculator
Answer a few questions and get a personalized compliance checklist for your products.
European Food Manufacturer Case Study
How a first-time European exporter successfully entered the US market.
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