FAQs
International & Foreign Manufacturer

Q19: What do international IVD manufacturers need to know before submitting to FDA?

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Foreign IVD manufacturers entering the U.S. market face several requirements that have no direct equivalent in EU IVDR, Japan's PMDA system, or most other regulatory frameworks. The first steps are to designate a U.S. Agent, complete FDA establishment registration, and list your device in FDA's device listing system.

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Certifications and approvals in other markets will not apply in the U.S. market. The CE marking under EU IVDR does not automatically map to an FDA regulatory classification or pathway. A Class C IVD under IVDR may be Class II or Class III under FDA classification. And the clinical evidence requirements for a U.S. submission may be substantially different than what worked in other markets. 

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Clinical performance data generated outside the U.S. is often acceptable to FDA, but only when the study population, specimen collection, and testing conditions are representative of U.S. clinical practice. Before designing clinical studies intended to support a U.S. submission, foreign manufacturers should confirm the acceptable comparator method with FDA through a pre-submission meeting. Landrich Group supports foreign manufacturers through the full FDA market entry process.

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