TL;DR
FDA clearance lets you market the device in the US. It does not make US buyers ready to buy from a company based abroad. In the first 90 days, a non-US manufacturer needs five things: establishment registration and device listing with a named US agent, a US website written to the US cleared indication, a decision on distributor or direct sales, a US contact who answers during US business hours, and one first trade show chosen for its buyers.
The question non-US device teams usually ask is "we are cleared, how do we start selling?" The question underneath it is "what does a US surgeon, hospital buyer or distributor need to see before they will take a company from another country seriously?" This article answers both, in the order the work has to happen. Your regulatory team owns the filings. Marketing's job is to know they are done and to build everything a US buyer sees.
What FDA clearance does not cover for a company based outside the US
A 510(k) clearance, De Novo grant or PMA approval answers one question: may this device be marketed in the US for this indication. It does not register your factory, name your US agent, or tell a hospital how to buy from you. Those are separate steps, and some of them must be finished before the first shipment arrives.
Two points catch non-US teams most often:
- CE marking is not FDA. CE marking is a European conformity mark, not an FDA authorization, and it should not appear in US materials as if it supports a US claim. Your US marketing rests on your US authorization alone.
- Your US indication may be narrower than your home-market label. The indications for use statement FDA cleared is the one you market to in the US. For 510(k) devices it is public in FDA's 510(k) database, where hospital reviewers and competitors can read it.
Registration, device listing and a US agent: what the regulation requires
21 CFR 807.40 requires any foreign establishment that makes a device imported or offered for import into the US to register the establishment and list its devices with FDA, and to name one US agent who resides or maintains a place of business in the US. The same section says no device may be imported or offered for import unless it is listed and made at a registered establishment. What that means in practice:
- Timing. Every year, registration and a review of every device listing take place between October 1 and December 31 (21 CFR 807.22). A missed update puts the establishment in "failed to register" status.
- Fee. For FDA fiscal year 2027 (October 1, 2026 to September 30, 2027), the annual establishment registration fee is $13,785, according to FDA's notice in the Federal Register, published July 30, 2026.
- The US agent's job is limited. On FDA's request, the agent helps FDA communicate with you, answers questions about your imported devices, and helps schedule inspections. If FDA cannot reach you directly or quickly, it may deliver documents to the agent, and that counts as delivering them to you. FDA's US agents page adds that the agent cannot use a post office box or only an answering service.
- Your importers are on file. Under 21 CFR 807.41, you report the importers of your devices and anyone who imports or offers them for import, including agents and brokers you use. Your distributor decision shows up in your FDA filing.
- English. Registration and listing information must be in English (21 CFR 807.40(d)), and the words and statements required on device labels and labeling must appear in English, with limited exceptions for certain standardized symbols explained in a symbols glossary, and for Puerto Rico and some US territories (21 CFR 801.15).
One rule belongs in every marketing brief. 21 CFR 807.39 says registration or a registration number "does not in any way denote approval of the establishment or its products," and that implying official approval because of registration is misbranding. Never use "FDA registered" as a selling line, and never place a registration number where it reads like an endorsement. Buyers can check your status themselves in FDA's public registration and listing database.
What to change on your website before you promote in the US
A translated home-market site carries claims, products and proof written for another regulator.
- Separate US pages from the rest of the world. Build a US site or a clearly separate US section, and send US ads and US search traffic there. Keep products that are not cleared in the US off US pages and out of US ads, and ask your regulatory lead how they should appear anywhere a US visitor can reach.
- Rewrite claims to the US indication, page by page. Keep a note of the source for every claim. I will not re-teach claims here; start with what you can and cannot say after 510(k) clearance and the difference between cleared and approved.
- Check every piece of home-market proof. Testimonials, case photos and study summaries may describe uses outside the US indication, or you may not hold US rights to them.
- Give US visitors US details. A US phone number, business hours stated in a US time zone, quotes in US dollars, and US spelling.
- Use one domain and one analytics setup. Duplicate country domains and split tracking make it impossible to tell what US visitors did. Consolidate before any ad spend, so every form and call is counted in one place.
- Send the form to a person. A US inquiry should reach someone who can reply the same US business day.
Distributor or direct: how to decide for the US
This is a business decision first. It changes what your marketing has to do.
| Question | US distributor | Direct (your own US team) |
|---|---|---|
| Who owns the customer relationship | The distributor, unless your contract says otherwise | You |
| Who controls what is said about the device | You supply materials; the distributor's reps say the words | You |
| Who pays for local marketing | Often shared, through co-op or marketing development funds | You |
| What your website must do | Tell buyers how to buy through the distributor | Capture and route inquiries to your own team |
The FDA side follows the choice. According to FDA's chart of who must register, list and pay the fee, an initial importer registers and pays the fee and identifies the manufacturers it imports from instead of listing devices, a domestic distributor that does not import devices does not register, and a relabeler or repackager registers and lists (21 CFR 807.20). Settle who plays which role before the contract is signed.
Two points from the marketing side:
- Give a distributor approved US materials. Do not let a partner translate your home-market brochure. Its claims become your problem. Our guide to distributor marketing programs covers what to supply.
- Decide who your website speaks to first. A site built to recruit distributors reads differently from one built for surgeons. Pick the reader who matters most in year one. Show your manufacturing strength as evidence that you can supply the US reliably, not as the whole story.
Who answers when a US customer calls
Your US agent is not your customer contact. A US hospital or surgeon who calls needs a person who can answer questions about the product, pricing and delivery.
- Name a person and publish US hours. For example, "Monday to Friday, 8 a.m. to 5 p.m. Eastern." If your team is abroad, set working hours that overlap with the US, or hire a US-based rep or partner who can take calls.
- Route complaints to quality the same day. A website form or phone line will eventually receive a product complaint. 21 CFR Part 803 requires manufacturers and importers to report deaths and serious injuries their device may have caused or contributed to, and certain malfunctions. Whoever answers must know where a complaint goes.
- Make it easy to pay you. Quote in US dollars, name the legal entity that invoices, and tell buyers early if payment goes by international wire.
- Know the rules on paying US physicians. Under CMS's Open Payments rules, an applicable manufacturer includes a company that makes a covered device and is "operating in the United States," which covers acting through a legally authorized agent (42 CFR 403.902). Applicable manufacturers report payments and other transfers of value to covered recipients, such as physicians and teaching hospitals, every year, with categories that include consulting fees, food and beverage, and travel (42 CFR 403.904). Ask counsel whether this applies to you before you pay a US surgeon to train, speak or advise.
Choosing your first US trade show
For most non-US device companies, the first US show should be the one where the users of the device are, usually a specialty society's annual congress, not the biggest general show. How to choose where to exhibit covers the selection.
Before you commit:
- Decide whether you need a booth at all. If you do not yet have US users who will talk about the device, attending and booking meetings ahead may do more for you. I cover that decision in whether an early device company should buy a booth at its first big congress.
- Review every show piece for US claims. Booth graphics and handouts made for a home-market show often carry claims or products that do not belong at a US show. See the FDA conference compliance guide.
- Book meetings before you fly. US clinicians, distributors and hospital buyers who already know you are coming are worth more than walk-by traffic.
GPO contracts and value analysis: what a US hospital will ask a new supplier for
Many US hospitals buy through group purchasing organizations (GPOs) and review new products through a value analysis committee before anyone can order. Treat a GPO contract as a later goal. In the first 90 days, have the information packet ready so the first interested hospital does not wait on you:
- FDA clearance number and the cleared indication
- Instructions for use and product specifications
- US pricing and how the product is ordered and shipped
- A summary of the clinical evidence, written for a committee that includes non-clinicians
- Reimbursement information, if it applies to your device
- A US contact for supply questions and complaints
As a new supplier from outside the US, expect extra questions about where the product ships from, lead times, and whether you hold inventory in the US. Answer them in the packet. For more, see marketing to value analysis committees and getting on GPO contracts.
A 90-day order of work after clearance
Days 1 to 30
- Confirm with your regulatory lead that registration, listing and the US agent are done.
- Pull the exact cleared indication and share it with everyone who writes copy.
- Audit the website and every sales piece against it.
- Decide distributor, direct, or both.
- Name the US contact and publish US hours.
Days 31 to 60
- Publish the US pages and fix tracking so every form and call is counted.
- Build the hospital information packet.
- Give partners approved US materials.
- Choose the first show and start booking meetings.
Days 61 to 90
- Start paid search with one campaign per specialty you sell to, not one general campaign.
- Attend or exhibit, and follow up within the week.
- Review what came in: who inquired, from where, and what they asked. Change the site and campaigns to match.
What does not work when entering the US market
- Translating the home-market site and switching it on for US visitors.
- Listing the US agent as the sales contact.
- One ad campaign for every specialty and every buyer.
- A large booth at the first US show, before any US customer can vouch for you.
- "FDA registered," or "FDA approved" for a 510(k) device, as a selling line.
How Buzzbox Media helps companies entering the US
Buzzbox Media builds the part of US market entry that buyers see: a US website written to your cleared indication and reviewed with your regulatory team, tracking that counts real inquiries, US search campaigns by specialty, and your first trade show plan. We do not act as a US agent or file FDA registrations; a regulatory consultant does that. See what our medical device marketing agency work covers, or book a free consultation and bring your cleared indication.