21 CFR Part 812
Under 21 CFR 812.18(a), a US person must hold every sponsor obligation for an IDE study; the regulation names one role, the sponsor. US sponsor representation is the term representation firms use for that role. The real question is what the agreement actually obliges the provider to do.
The Rule
21 CFR 812.18(a) names a single role for the foreign manufacturer's US counterpart in an IDE study: the sponsor. A marketing label on a service does not create a second role beside it.
"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 →"A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a))."
FDA, FAQs About Investigational Device Exemption. Read the FDA FAQ →"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 (contrast: a US Agent is a different, narrower role). Read the FDA page →A Note on Terminology
"Representative" is a term from EU MDR Article 11 (the authorized representative, a manufacturer's legal presence in the EU market) and Article 62 (the legal representative for clinical investigations). Firms that offer those EU roles carried the same word into US marketing material.
The United States has no equivalent "representative" construct for IDE studies; Part 812 recognizes the sponsor and, separately, a Part 807 US Agent. US sponsor representation is a representation firm's term for the Part 812 sponsor role itself, built on EU vocabulary rather than a distinct US category. A US "representation" agreement therefore has to obligate the provider as a sponsor under Part 812 to function as one, whatever its name on the invoice.
Side by Side
| Communications representative | Accountable sponsor of record | |
|---|---|---|
| What the agreement covers | Correspondence, submissions filing, IRB liaison | Full 21 CFR 812 Subpart C obligation set |
| Who FDA holds accountable | The named sponsor, not this role | The named sponsor |
| Monitoring | Not included | Included, 21 CFR 812.40 |
| Safety reporting | Not included | Included; UADE reported within 10 working days |
| Device accountability and import | Not included | Included |
| Records and inspection | Not included | Included, records held for the prescribed retention period and produced at a BIMO inspection |
| Typical pricing basis | Annual fee (public pattern, no figure published here) | Initiation plus engagement budget; from $2,495 initiation for nonsignificant risk studies, from $3,500 initiation for significant risk studies |
Before You Sign
A provider that answers yes to all seven is a sponsor of record, whatever the service is called.
How ADB Holds the Role
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 → · US Agent versus US Sponsor of Record →
Common Questions
US sponsor representation is a term some firms use to market the role that 21 CFR 812.18(a) calls the sponsor. It is not a separate or lesser regulatory category; whoever performs it holds the same sponsor obligations, under whatever label it is sold under.
No. A US Agent under 21 CFR 807.40 only receives FDA correspondence for establishment registration and carries no clinical study liability. A US sponsor representative offering sponsor services is describing the Part 812 sponsor role, a different and larger set of obligations.
Yes, if the agreement makes it the sponsor under Part 812. The service name on the invoice does not determine accountability; what the written agreement obliges the provider to do under 21 CFR 812 Subpart C does.
Reviewed October 18, 2026 by ADB's regulatory team.
Ask the Seven Questions. We Answer Yes.
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.