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International Track

Enter the US market from abroad. The whole pathway, in plain English.

For non-US manufacturers preparing to sell medical devices into the United States.

Audience. International medical device manufacturers, EU-based RA teams, exporters expanding to the US.6 chapters · ~88 min · 11 articles
  1. 1

    Why FDA clearance matters globally

    FDA clearance unlocks more than the US market - it's a credential other regulators read.

    FDA Clearance Is a Global Strength. Here’s Why It Matters Beyond the U.S.Apr 15, 2026 · ~8 min readWhy More International Medical Device Manufacturers Are Entering The US MarketMar 11, 2026 · ~8 min read
  2. 2

    US vs EU - how the pathways differ

    510(k) vs CE marking. MDR vs FDA. Where the evidence bars match and where they don't.

    EU MDR vs FDA: US-EU Medical Device Regulatory Comparison GuideAug 10, 2025 · ~8 min readCE Mark vs FDA 510(k): EU MDR and US Regulatory Pathway ComparisonMar 8, 2026 · ~8 min read
  3. 3

    Can you reuse CE Mark clinical data?

    When FDA accepts EU clinical evidence, when it doesn't, and how to bridge the gap.

    Can I Use My CE Mark Clinical Data for FDA 510(k)? Complete GuideMar 14, 2026 · ~8 min read
  4. 4

    US Agent and FDA registration

    FURLS setup, the US Agent role, annual fees, device listing - the establishment basics.

    US Agent Requirements for International Medical Device Manufacturers: Complete GuideMar 3, 2026 · ~8 min readHow to Register Your Medical Device Company with FDA: FURLS Setup, Fees, FDA registration and Device ListingApr 21, 2026 · ~8 min read
  5. 5

    Importing without getting stopped at the border

    Import alerts, refusals, and the initial importer's responsibilities.

    FDA Import Alerts: A Guide for International Medical Device CompaniesNov 21, 2024 · ~8 min readHow To Import Medical Devices: FDA Initial Importer Complete GuideAug 18, 2025 · ~8 min readFDA Import Refusals for Medical Devices: Causes, Process, and Tips to Avoid ThemNov 14, 2024 · ~8 min read
  6. 6

    The expensive mistakes to avoid

    Patterns we see again and again from international teams entering the US.

    10 Expensive Mistakes International Medical Device Manufacturers Make Entering the US MarketMar 19, 2026 · ~8 min read
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