What I Tell Every Foreign Company About Bringing Class I Devices to the US

I've guided dozens of international life sciences companies through FDA market entry. Class I medical devices should be the easy path—lowest risk category, and most skip the lengthy 510(k) clearance process entirely.

And yet, I watch smart companies stumble on the same problems again and again.

Here's what I wish someone had told me when I started doing this work.

Everyone gets the timeline wrong

Most guides say 4-8 weeks for Class I device entry. That number isn't wrong. It's just incomplete.

8-12 weeks is realistic if you're well-prepared. You've already identified your US Agent. Your labeling is mostly done. Someone on your team knows the FDA systems.

3-6 months is more honest if you're starting fresh. No US contacts, no regulatory experience. Learning everything as you go.

I've lived both scenarios. The difference comes down to parallel execution and avoiding a handful of predictable traps.

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The five steps and where they usually break down

Step 1: Confirming Your Classification

This takes a few days if you know what you're looking for.

You search the FDA Product Classification Database and confirm two things: your device is Class I, and it's 510(k) exempt.

Here's the trap. Some Class I devices are what FDA calls "reserved devices." These still require 510(k) clearance despite their low-risk label. Miss this detail and you've just added 3–6 months to your timeline.

I always tell clients to verify exemption status before they spend a dollar on anything else.

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Step 2: Appointing Your US Agent

Every foreign manufacturer needs a US-based representative. No exceptions.

Your US Agent handles FDA communications. They coordinate inspections. They must have a physical US address and be available during US business hours.

This step takes 1–2 weeks and runs parallel to classification verification.

The hidden dependency that catches people: your US Agent must confirm their appointment within 10 business days of your registration submission. FDA sends them an automated email. If they miss it or respond late, your entire process stalls.

I've watched timelines slip by weeks because nobody followed up on that confirmation email.

Typical cost runs $1,000–$5,000 annually. Engage early—we can help you get this covered.

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Step 3: Registering with FDA

You cannot start registration until your US Agent is appointed and documented. I've seen companies try to skip ahead. It doesn't work.

The annual establishment fee for FY 2026 is $11,423. Foreign establishments get no small business exemption.

The process itself takes 5–7 business days:

1. Pay the fee
2. Receive your credentials
3. Complete registration in the FURLS system
4. List your devices
5. Wait for your US Agent to confirm.

You'll receive an FDA Facility Establishment Identifier number and listing confirmation. But remember: registration isn't final until your US Agent confirms. Plan accordingly.

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Step 4: Building Your Compliance Documentation

This is your longest lead-time item. One to two months is realistic. Start immediately—don't wait for registration to complete.

Labeling is where most foreign manufacturers stumble. Your labels need:

• Manufacturer name and address
• US importer information
• Intended use
• Adequate directions
• Required warnings
• Lot identification
• UDI (if your device type requires it)

Budget 4-6 weeks for drafting, legal review, translation if needed, artwork finalization, and print production.

Labeling causes more import detentions than any other issue. I've seen shipments held for weeks over missing warnings or unclear directions. Invest the time upfront.

You also need quality system documentation: written complaint handling procedures, records control, and labeling control to prevent mix-ups.

And you need Medical Device Reporting (MDR) procedures: written processes for identifying deaths, serious injuries, and certain malfunctions, plus electronic submission capability through FDA's gateway.

None of this is optional – even with Class I exemptions.

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Step 5: Coordinating Your Import Entry

Two things happen here, and both take time.

Your US importer must separately register with FDA. Same $11,423 fee. If they're not already registered, add 2–3 weeks to your timeline.

I always tell clients to identify their importer by Week 4 at the latest.

Your customs broker needs a complete data package: registration codes, listing numbers, FDA product codes, and commercial documentation.

First import reality check:

Best case: "May Proceed" in 1-3 business days.
What actually happens: 30-40% of first-time foreign manufacturer entries receive a "Request for Information." This adds 5-10 days while you respond through FDA's ITACS system.
Worst case: Detention for non-compliance. Weeks or months of delay.

I always build contingency into first-shipment timelines. The learning curve is real.

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I see similar mistakes time and time again

Assuming all Class I devices are 510(k) exempt. Some aren't. Check the classification database. A missed "reserved device" designation costs 3–6 months.

Starting labeling too late. Labeling should begin Week 1, parallel with registration—not after.

Registering before the US Agent confirms. Registration fails. You restart everything.

Incomplete import entry data. One wrong code triggers an information request. Triple-check everything with your broker before the first shipment.

Forgetting about the importer. Your US importer needs their own FDA registration. Same fee. Same timeline. Plan for it.

Weak complaint and MDR procedures. FDA conducts unannounced inspections at foreign facilities now. Poor documentation leads to 483 observations, warning letters, and import alerts.

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What are the costs?

Initial market entry runs $17,000-$65,000 depending on how much you do in-house versus with consultants.

Annual recurring costs run $27,000–$42,000 or more: registration renewal, US Agent, importer registration (if separate), customs brokerage, and quality maintenance.

These numbers increase 5-25% annually. Budget for it.

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Let's summarize

The 4-8 week timeline is achievable – but only when:

• Classification and exemption are pre-confirmed
• US Agent and importer are already contracted
• Labeling is substantially complete before registration
• You have regulatory expertise in-house or engaged
• Activities run in parallel, not sequentially

Most foreign manufacturers should plan at least six months from kickoff to first commercial shipment cleared through US Customs.

Build in buffer for learning curves and information requests. They're more common than the guides suggest.

At Arcstone, we partner with international life sciences companies navigating US market entry. We don't hand you a playbook and walk away—we operate alongside you through every step, from classification verification to your first cleared shipment.

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