Free Tool · Two Minutes · Five Questions
Under 21 CFR 812.18(a), a company outside the United States cannot itself sponsor an FDA IDE study; a US person must act as sponsor and hold every Part 812 obligation. This tool is for non US device manufacturers planning a US clinical study. Answer five questions, about two minutes, for your sponsor options.
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 three structures below cover the sponsor role, not the US Agent role.
21 CFR 812.18(a) is triggered by import: 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. That is why who imports the device matters to the analysis, even though it does not change which of the three sponsor structures above is available to you.
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.
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.
Readiness Assessment calls are typically scheduled within a few business days of inquiry, with the written assessment delivered shortly after. FDA's own IDE review clock under 21 CFR 812.30 is 30 calendar days once your IDE application is filed.
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.