21 CFR Part 807 · 21 CFR Part 812
Under 21 CFR 807.40, a US Agent is a registration liaison who receives FDA correspondence and has no responsibility for adverse event reporting or premarket submissions. Under 21 CFR 812.18(a), a US sponsor holds every Part 812 obligation for an IDE study. One role does not become the other by contract wording.
The Rule
A Part 807 US Agent is a registration liaison with no study responsibility. A Part 812 sponsor holds every sponsor obligation. The two roles are governed by different regulations, serve different FDA purposes, and are never interchangeable.
"In addition to complying with other requirements of this part, a person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the sponsor of the clinical investigation, or ensure that another person acts as the agent of the foreign exporter and the sponsor of the investigation."
21 CFR 812.18(a). Read the full section on eCFR →"Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E)."
FDA, U.S. Agents. Read the FDA page →What Goes Wrong
Side by Side
| US Agent (21 CFR 807.40) | US Sponsor of Record (21 CFR 812.18(a)) | |
|---|---|---|
| Legal basis | 21 CFR Part 807 | 21 CFR Part 812 |
| Purpose | FDA correspondence liaison for commercial establishment registration | Holds every IDE obligation for a clinical study |
| Responsibilities | Receive correspondence, facilitate inspection access, manage annual renewal | IDE application, FDA correspondence, investigator oversight, monitoring, safety reporting |
| Liability | None for adverse event reporting or premarket submissions (FDA, U.S. Agents page) | Full Part 812 accountability for the study |
| Who typically provides it | A registration or compliance firm, or a mailbox service | A contracted sponsor of record, a US subsidiary, or a sponsor investigator |
| Typical cost | $595 per year | From $2,495 initiation (nonsignificant risk) to $3,500 initiation (significant risk) |
A Note on Terminology
Some firms market the phrase "US sponsor representation" for the role 21 CFR 812.18(a) actually requires. The phrase is a representation firm's term for the Part 812 sponsor role itself, not a lesser or different service; whoever performs it still holds the full obligation set, under whatever label it is sold under.
The Three Structures
A non US manufacturer has three structures available to satisfy 21 CFR 812.18(a):
See the full US Sponsor of Record tier structure → · Use the decision tool → · Download the obligations checklist →
Common Questions
A US Agent (21 CFR 807.40) only receives FDA correspondence on a foreign establishment's behalf and carries no clinical study responsibility. A US Sponsor of Record (21 CFR 812.18(a)) assumes full legal accountability for an IDE study's conduct, monitoring, and reporting.
Not automatically. A US Agent designation under 21 CFR 807.40 and a sponsor of record designation under 21 CFR 812.18(a) are two separate legal roles with separate obligations. The same firm can hold both, but only if it is separately engaged and formally designated as sponsor, not by virtue of already being the US Agent.
Yes. 21 CFR 812.3(n) lets a sponsor transfer specific obligations to a contract research organization in writing, but unless every obligation transfers, the sponsor remains legally accountable for the rest. ADB can serve as the full named sponsor of record, not just a delegated functions vendor.
Reviewed October 18, 2026 by ADB's regulatory team.
Need a Named Sponsor in Place?
For a scoping review of your specific study, start with the Sponsor Readiness Assessment on the US Sponsor of Record page, or reach the practice group directly.