21 CFR 812.20 · Subpart C · 812.140 · 812.150
812.20 governs the IDE application itself; full sponsor responsibility runs from 812.20 through Subpart C (812.40 to 812.46) and the records and reporting requirements at 812.140 and 812.150. When the manufacturer is outside the United States, 812.18(a) requires a US person to hold every one of these obligations.
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 →812.20 · 812.25 · 812.27 · 812.35
812.20 is the application itself: the sponsor's formal request to FDA for an exemption to ship and study an investigational device. 812.25 and 812.27 require the investigational plan (objectives, protocol, risk analysis, monitoring procedures) and a report of prior investigations supporting the study. 812.35 governs every later amendment and supplement as the protocol or device changes.
The sponsor signs the IDE application and its cover letter, not the US Agent and not an investigator alone. The cover letter identifies the sponsor by name and address; that name is the entity FDA addresses for the life of the application, including every future amendment, supplement, and piece of correspondence.
Subpart C
812.140(b) · 812.150(b)
| Obligation | Section | What It Means in Practice |
|---|---|---|
| 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. |
| 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. |
The 10 working day clock on an unanticipated adverse device effect runs from when the sponsor first learns of it, not from when a formal written report reaches the sponsor's office. A sponsor without a direct, ongoing line to every investigator cannot reliably start that clock on time.
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 page 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. A non US manufacturer has three structures available to satisfy 21 CFR 812.18(a):
See the full US Sponsor of Record tier structure → · Download the full obligations checklist → · Use the decision tool →
Common Questions
The sponsor owns the IDE application and amendments (812.20, 812.35), FDA correspondence (812.40), investigator selection and signed agreements (812.43), IRB coordination (812.42), monitoring and investigator compliance (812.46), informing investigators (812.45), and records and reports to FDA (812.140, 812.150). These obligations attach to the sponsor by regulation and cannot be delegated away.
Execution of a task can be assigned by written agreement, for example to a contract research organization, but accountability to FDA for the obligation itself stays with whoever holds the sponsor of record designation. An obligation never specified in writing stays with whoever held it going in.
A UADE is an unanticipated adverse device effect, any serious adverse effect on health or safety not identified in nature, severity, or degree of incidence in the investigational plan or application. Under 21 CFR 812.150(b), the sponsor reports a UADE to FDA and all reviewing IRBs within 10 working days of first learning of it.
Reviewed October 18, 2026 by ADB's regulatory team.
Need a Named Sponsor in Place?
For a scoping review of your specific study against these obligations, start with the Sponsor Readiness Assessment on the US Sponsor of Record page, or reach the practice group directly.