First-Time FDA Registration for Foreign Device Manufacturers: A 90-Day Playbook

We often see manufacturers attempt to register the week before their first shipment departs. This is a critical error. FDA systems do not synchronize instantly, and obtaining a Facility Establishment Identifier (FEI) can take weeks. A 90-day horizon allows for a controlled, risk-free entry.

Phase 1: Days 1–30 (The Data Foundation)

Before you pay any fees, you must establish your digital identity. This starts with a DUNS number for your specific manufacturing address. If your DUNS data (legal name, physical address) does not perfectly match what you intend to tell FDA, the system will reject your registration. During this phase, you must also appoint your U.S. Agent. This is not merely a mail drop; the U.S. Agent is your official regulatory representative, required to answer FDA inquiries and assist with inspection scheduling. Choosing a professional agent early ensures you have a compliant communication channel in place.

Phase 2: Days 31–60 (Execution & Payment)

With your DUNS secured and U.S. Agent appointed, you proceed to the FDA Unified Registration and Listing System (FURLS). You will pay the annual Medical Device User Fee (MDUFA) for the fiscal year. Once payment clears (typically 2–3 days), you perform the Establishment Registration. This generates your Preliminary Registration Number, which acts as your temporary license to operate while FDA assigns your permanent FEI number.

Phase 3: Days 61–90 (Device Listing & Import)

Registration opens the door; Device Listing moves the product. You must list every device you intend to export, selecting the correct Product Code and Regulation Number. If you are 510(k) exempt, you must verify your exemption status. If you hold a 510(k), the listing must match the clearance exactly. Finally, you must coordinate with your Initial Importer—the U.S.-based entity that physically receives your goods. They must also be registered with FDA to avoid "importer mismatch" holds at the border.