21 CFR Part 812
Under 21 CFR 812.18(a), the sponsor named on the IDE carries Part 812 accountability for the study. A CRO performs delegated work, but FDA's own compliance program states Part 812 does not provide for transfer of sponsor obligations to a CRO. The manufacturer keeps product and quality system responsibility. When the manufacturer is foreign, a US person must be that sponsor.
The Rule
A company outside the United States cannot itself sponsor an FDA IDE study; a US person must act as sponsor and carry every sponsor obligation in Part 812.
"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 →"The term 'sponsor' also refers to any entity to whom one or more of the obligations of the sponsor has been transferred in writing."
FDA Compliance Program 7348.810, Sponsors, Contract Research Organizations and Monitors. Read the compliance program →Part 312, the parallel framework for drug studies, lets a sponsor transfer any or all obligations to a CRO in writing under 21 CFR 312.52; Part 812, the device framework this page covers, has no equivalent transfer provision, so an obligation never specified in writing stays with the sponsor regardless of who performed the work.
Who Carries What
The Split
Accountability to FDA for an obligation stays with the sponsor of record. Execution of a task can be assigned by written agreement. The table below marks both.
| Obligation | Sponsor (Accountable) | CRO (Delegable Execution) | Manufacturer |
|---|---|---|---|
| IDE application & supplements (812.20, 812.35) | Signs and files; accountable for accuracy | May draft or compile under written transfer | Supplies device and technical data |
| Investigational plan & prior investigations (812.25, 812.27) | Accountable for the plan FDA reviews | May author under written transfer | Supplies preclinical and device data |
| Investigator selection & signed agreements (812.43) | Accountable for the qualification judgment | May manage agreement paperwork and logistics | Not applicable |
| Monitoring & UADE evaluation (812.46) | Accountable for the halt decision and evaluation | May perform monitoring visits | Reports known device issues to the sponsor |
| Informing investigators (812.45) | Accountable for keeping investigators current | May distribute materials | Supplies current investigator brochure content |
| Labeling & promotion prohibition (812.5, 812.7) | Accountable for compliance | Not applicable | Executes labeling; controls promotion |
| Records & reports to FDA (812.140, 812.150) | Accountable as the named party | May maintain records under written transfer | Supplies device disposition and complaint data |
| UADE report within 10 working days (812.150(b)) | Accountable duty holder for the clock | May draft the report | Notifies the sponsor of known issues promptly |
A Note on Insurance and Indemnity
A sponsor of record typically carries clinical trial liability coverage sized to the study it names. A manufacturer typically indemnifies the sponsor for defects in the device itself, separate from the sponsor's own conduct of the study. A mail drop agent will not accept the sponsor role precisely because underwriters price the coverage against the oversight actually exercised, not against an address. This is not legal advice; consult counsel on the specific insurance and indemnity terms for your study.
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
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.
FDA inspects the sponsor of record named on the IDE application, not merely the CRO performing delegated tasks. An obligation never documented as transferred in writing stays with the sponsor regardless of who executed it operationally.
Withdrawal of sponsor approval is itself a reportable event under 21 CFR 812.150(b). The study cannot continue without a new sponsor accepting the full obligation set, and FDA and all reviewing IRBs must be notified of the withdrawal.
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.