Food
A foreign food facility that must register with FDA designates one U.S. Agent in its food facility registration. The agent is the communication link for routine and emergency FDA contact.
FDA facility contact
U.S. Agent service for foreign facilities
FDABridge offers U.S. Agent coverage in selected registration services and considers appointment, transfer or continued coverage after reviewing the facility and its FDA record. Tell us your product category and current registration status to request a written scope and quote.
Request a U.S. Agent quoteWhat the appointment covers
The agreed service identifies FDABridge as the U.S. Agent in the applicable FDA facility record, subject to the facility's authorization and FDA acceptance. We serve as a contact point for FDA communications relevant to that role and route those communications to the facility. The completion evidence is the applicable FDA record and accepted designation.
Where Year 1 coverage is included in a listed registration package, it lasts 12 months from the effective, accepted designation. Coverage does not renew automatically. A separate written scope, quote and payment are needed for continuation. A standalone appointment or transfer is quoted after the category and record are checked; no standalone price is published.
The correct FDA context matters
Cosmetics
For a covered foreign cosmetic manufacturing or processing facility, the facility registration includes U.S. Agent contact information. This role is separate from the responsible person identified for cosmetic products.
Drugs
A foreign drug establishment subject to registration identifies one U.S. Agent. FDA communications about registration, imported drugs and inspection scheduling are part of the regulatory role.
Medical devices
A foreign device establishment identifies one U.S. Agent in the registration process. The role can assist FDA communications and inspection scheduling, but does not itself include adverse event reporting or a 510(k) submission.
Scope and limits
Agent coverage by itself does not include DUNS or FEI work, registration or renewal filings, amendments, product listings, label review, Prior Notice, FSVP or importer services, laboratory work, customs brokerage, legal representation, inspection responses, or Import Alert and detention work. Those require a separately agreed service where available.
An Agent designation is not FDA approval or an import-clearance guarantee. The facility remains responsible for its own regulatory obligations and for keeping its FDA record accurate. If an existing Agent is named, we will clarify the transfer and effective date before any replacement.