For Non-U.S. Manufacturers
A single U.S. team serving as U.S. Agent, official correspondent, and IDE Sponsor of Record for non-U.S. device manufacturers entering the U.S. market.
The International Sponsor Program puts a single U.S. team in three FDA-facing roles for a non-U.S. manufacturer: U.S. Agent under 21 CFR 807, official correspondent for premarket submissions, and — where the program includes a U.S. clinical study — U.S. Sponsor of Record for an Investigational Device Exemption under 21 CFR 812. The point of combining all three under one team is simple: FDA always has a single, reachable U.S. counterpart, and the manufacturer always has a single accountable practice director rather than a fragmented set of vendor relationships.
Every piece of written FDA correspondence is handled and logged by the director of record, so nothing sits in an inbox waiting on a time-zone overlap. Documents, milestones, and FDA letters live in a secure client portal at app.adbccro.com rather than scattered across email threads, and the NDA, MSA, and statement of work are all executed by electronic signature so a sponsor overseas is never blocked on a courier or a wet-ink requirement. Calls are scheduled in the client's morning where overlap allows, and all working documents are in English. To be direct about it: ADB is a U.S. firm serving non-U.S. sponsors from the United States — there is no in-country office or non-English-language service, and we don't represent otherwise.
A question that comes up often: what happens to an existing FDA submission file when a sponsor changes its U.S. representative. At the most basic level, it requires a letter from the sponsor to the lead FDA reviewer identifying the new correspondent, with the outgoing correspondent's acknowledgement — this needs to happen before a new Pre-Submission or IDE amendment can reference an earlier Q-number or study file without creating confusion on FDA's side. ADB manages this handoff cleanly in either direction, whether a sponsor is transitioning to ADB or transitioning away from ADB at the end of an engagement.
Most of ADB's international sponsors have come from South Korea, Israel, India, and the United Kingdom, and each has a dedicated page. The program is open to manufacturers from any country; the same team, process, and U.S. Agent and Sponsor of Record services apply.
Common Questions
21 CFR 807.40 prohibits a U.S. importer from simultaneously serving as the U.S. Agent, so a distributor relationship does not satisfy the requirement on its own. A foreign establishment still needs a separately designated U.S. Agent before FDA establishment registration can complete, regardless of any existing distributor arrangement.
A non-U.S. company can run a U.S. IDE study, but FDA requires a U.S.-based sponsor contact for it — which is what a U.S. Sponsor of Record under 21 CFR Part 812 provides. The U.S. Sponsor of Record takes on the full set of sponsor obligations for the study on the foreign company’s behalf.
The U.S. Sponsor of Record assumes the full set of 21 CFR Part 812 sponsor obligations for an IDE study — monitoring oversight, FDA reporting (annual and final reports, unanticipated adverse event reports), investigator agreements, and direct accountability to FDA for the conduct of the study.
Yes — ADB’s International Sponsor Program is built around exactly this split: a home-market CRO or regulatory partner continues handling local-market work, while ADB serves as U.S. Agent, official correspondent, and where required U.S. Sponsor of Record for the FDA-facing side of the program.
Program documents, FDA correspondence, and milestones are managed through a secure client portal rather than email attachments, under the mutual NDA executed at engagement start. Electronic signature is used for the NDA, MSA, and SOW so an international sponsor is never blocked on a wet-ink signature requirement.
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30 minutes to assess your U.S. Agent, submission, or IDE sponsor needs.