Two names on one registration, two jobs

A foreign device establishment’s registration record — on FDA’s own site, and in openFDA’s copy of it — carries two named people, not one. They are easy to read as the same contact wearing two hats. FDA’s own rule gives only one of them a power the other doesn’t have, and the record itself keeps them in separate fields for exactly that reason.

The one FDA can legally treat as the firm

21 CFR 807.40 requires every foreign establishment that manufactures, prepares, or processes a device imported into the United States to name a United States Agent as part of its registration — one agent per establishment, residing or maintaining a place of business here. On FDA’s request, the agent assists FDA in communicating with the foreign establishment, answers questions about the establishment’s imported products, and helps schedule inspections. The clause that matters most sits at the end of the rule: when FDA cannot reach the foreign establishment directly or expeditiously, the agency may hand information or documents to the U.S. Agent instead, and that delivery counts as delivery to the foreign establishment itself. The agent is not a courtesy contact. It is a legal stand-in FDA can use.

The one who actually filed the form

A separate role, the Official Correspondent, is the person a registrant authorizes to submit its registration and listing data and to handle FDA communications about that filing specifically. A firm is free to name the same person as both its U.S. Agent and its Official Correspondent — a common setup — or to split the two across different people entirely. Nothing in Part 807 gives the Official Correspondent, acting only in that capacity, the equivalent-delivery power 807.40 gives the U.S. Agent. Filing the paperwork and standing in for the firm are two different grants of authority, and holding the first doesn’t confer the second.

The record keeps the split

openFDA’s own field reference for the registration and listing dataset carries the distinction as separate, named fields rather than one contact block: registration.us_agent holds the U.S. Agent’s individual name, business name, and address, and a separate set of official-correspondent fields — first name, last name, phone, company — holds the other. Two people, in two fields, on one establishment record. A lookup that surfaces only one name, or that treats whichever name appears first as “the contact,” is reading half the record FDA actually publishes.

The practice

Reading a foreign competitor’s or a foreign supplier’s registration record, check which of the two fields a name sits in before treating it as the establishment’s point of contact. Only the name in the U.S. Agent field carries FDA’s equivalent-delivery authority under 807.40 — the Official Correspondent doesn’t inherit that power just by having a name on the same filing. Per what we monitor and how often, this is regulatory intelligence and method for reading a public registration record, never regulatory advice about who a specific establishment should designate for either role — that decision belongs with the firm and its own regulatory counsel.