Expanding into the U.S. market requires adapting global approvals to FDA rules. Learn how to bridge gaps in classification, testing, labeling, and quality systems so international manufacturers can achieve compliance and succeed with U.S. device approvals.
Expanding into the U.S. market requires even seasoned international manufacturers to adjust their regulatory strategy. FDA requirements can differ significantly from Europe’s CE Mark or other global frameworks. A successful global-to-U.S. plan identifies and closes the gaps between your existing approvals and FDA’s expectations.
Begin by translating your device’s status into U.S. regulatory terms. The FDA may classify your device differently than regulators elsewhere. Use FDA’s product classification database to confirm how your product is classified (Class I, II, or III) and whether any exemptions apply. Even if you have a CE Mark or other approval, you must obtain the appropriate U.S. clearance or approval – via 510(k), De Novo, or PMA – before marketing in the U.S. Approval in other markets (such as a CE Mark) does not grant FDA approval. There is no reciprocity, so you must still pursue a full U.S. submission through the proper pathway.
Tip: If your device is novel or has no U.S.-marketed equivalent, be prepared that FDA might assign it to Class III (PMA) or require a De Novo, even if it was considered lower risk elsewhere. Engaging FDA early (through a Pre-Submission meeting) can clarify the expected classification and data needs, preventing surprises.
Perform a thorough gap analysis between your existing technical documentation and FDA’s expectations. FDA often has specific guidance documents or special controls that may not have exact counterparts in other jurisdictions. Key areas to review:
All foreign device manufacturers must appoint a U.S. Agent and register their establishment with the FDA before marketing in the U.S. The U.S. Agent serves as a point of contact for FDA communications. Along with establishment registration, you’ll list your device(s) in FDA’s database. These steps come with user fees and annual renewal requirements. Ensure you budget for the FDA registration fee and complete these registrations as you approach your U.S. launch date. (Note: registration and listing alone do not authorize marketing – you still need the proper FDA clearance or approval for your device.)
U.S. regulations include postmarket surveillance and quality obligations that may go beyond what you’ve encountered elsewhere. Make sure your quality system can handle:
By addressing these key areas – device classification, documentation gaps, U.S.-specific registrations, and quality system preparedness – international manufacturers can confidently approach the U.S. market. The overarching principle is to map everything you’ve done abroad to FDA’s framework, identifying where updates or extra evidence are needed. Many international companies seek expert help in this translation process. ADBC CRO specializes in guiding global device firms through FDA requirements, from initial gap assessments to submission preparation and postmarket compliance. With careful planning and adaptation, you can leverage your global regulatory successes as a foundation while avoiding common pitfalls in meeting U.S. FDA expectations.
