21 CFR Part 812, Subpart C
Under 21 CFR 812.18(a), the US sponsor of record owns every Part 812 obligation for an IDE study: the application, FDA correspondence, investigator oversight, monitoring, and safety reporting. A company outside the United States cannot hold this role itself. This checklist is for non US device manufacturers evaluating how to structure US sponsor accountability.
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 →"A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor."
FDA, FAQs About Investigational Device Exemption. Read the FDA FAQ →A related but separate role is the US Agent under 21 CFR Part 807, which only receives FDA correspondence for a commercial device establishment and carries no Part 812 clinical study obligations. The checklist below covers the sponsor role, not the US Agent role.
The Checklist
Every row below is an obligation that attaches to the sponsor by regulation. Execution of a task can be assigned by written agreement; accountability to FDA for the obligation itself stays with whoever holds the sponsor of record designation.
| Obligation | Section | What It Means in Practice | Who Typically Holds It |
|---|---|---|---|
| Submit the IDE application and supplements | 812.20, 812.35 | The sponsor files the original IDE application with FDA and submits every amendment or supplement as the protocol or device changes. | US Sponsor |
| Investigational plan and report of prior investigations | 812.25, 812.27 | The sponsor prepares the investigational plan (objectives, protocol, risk analysis, monitoring procedures) and compiles the prior investigation reports supporting the study. | US Sponsor |
| Act as agent and sponsor for imported devices | 812.18(a) | Whoever imports the investigational device into the United States must either act as the foreign exporter's agent and the study sponsor, or ensure another person holds both roles. | US Sponsor |
| General responsibilities of sponsors | 812.40 | The sponsor selects qualified investigators, supplies the information needed to conduct the study properly, ensures monitoring, and maintains required records. | US Sponsor |
| Obtain FDA and IRB approval before starting | 812.42 | No subject may be enrolled and no device shipped for the study until FDA (for significant risk studies) and the reviewing IRB have both approved the investigation. | US Sponsor |
| Select qualified investigators and monitors; obtain signed investigator agreements | 812.43 | The sponsor selects investigators qualified by training and experience, selects qualified monitors, and obtains a signed agreement from each investigator before shipping the device. | US Sponsor |
| Inform investigators (investigational plan, device information, new information) | 812.45 | The sponsor supplies every investigator with the investigational plan and a current investigator's brochure, and keeps them informed of new safety or effectiveness observations as the study proceeds. | US Sponsor |
| Monitor the investigation; secure compliance; evaluate unanticipated adverse device effects | 812.46 | The sponsor monitors investigator performance, acts (including halting the study) if an investigator fails to comply with the agreement or protocol, and evaluates and reports unanticipated adverse device effects. | US Sponsor |
| Device labeling; prohibition of promotion and commercialization | 812.5, 812.7 | Investigational devices must carry FDA required investigational use labeling, and the sponsor may not promote, test market, or commercialize the device as though already cleared or approved. | US Sponsor |
| Sponsor records: correspondence, shipment and disposition, investigator agreements, adverse effects | 812.140(b) | The sponsor maintains records of all correspondence with FDA and investigators, device shipment and final disposition, signed investigator agreements, and adverse device effect reports, available for FDA inspection. | US Sponsor |
| Sponsor reports: UADE within 10 working days, withdrawal of IRB or FDA approval, current investigator list, progress and final reports, recall and device disposition | 812.150(b) | The sponsor reports unanticipated adverse device effects to FDA and all reviewing IRBs within 10 working days, and submits withdrawal of approval notices, periodic progress reports, a current investigator list, and final and recall and disposition reports on FDA's schedule. | US Sponsor |
Why It Cannot Be Delegated Away
21 CFR Part 312, the parallel framework for drug studies, contains an explicit transfer of obligations provision at 21 CFR 312.52: a sponsor may transfer any or all Part 312 obligations to a contract research organization in writing, and the CRO becomes accountable for whatever is transferred. Part 812, the device framework this checklist covers, has no equivalent transfer provision.
FDA's own compliance program for inspecting sponsors, CROs, and monitors treats an entity holding transferred obligations the same as a sponsor, for the obligations it actually took on in writing:
"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 →An obligation never specified in that writing stays with whoever held it going in. Under Part 812, that is the sponsor of record, not a contracted CRO acting without a written transfer. A vendor performing tasks for a device study is not automatically the sponsor for 812 purposes; the sponsor designation and the obligations in the table above have to be held somewhere specific, by name, before FDA.
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 and the Sponsor Readiness Assessment →
Free Download
The PDF includes the full eleven obligation checklist table above, the quoted 812.18(a) rule, and a blank column so you can track which obligations your current structure already covers.
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Click below to download the US IDE Sponsor Obligations Checklist.
Download the Checklist (PDF)Common Questions
No. 21 CFR 812.18(a) requires an IDE sponsor to be a US resident, or to designate a US agent if the sponsor is located outside the United States. A foreign device company must put a US based sponsor of record or US agent in place before FDA accepts the IDE.
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.
ADB's published US Sponsor ladder runs from $2,495 initiation for nonsignificant risk studies to $3,500 initiation for significant risk studies, with an optional $4,500 Sponsor Readiness Assessment credited in full within 90 days. Full risk engagement budgets are confirmed in a Work Authorization after scoping.
Reviewed October 17, 2026 by ADB's regulatory team.
Need a Named Sponsor in Place?
For a scoping review of your specific study against this checklist, start with the Sponsor Readiness Assessment on the US Sponsor of Record page, or reach the practice group directly.