Three Ways to Run a US Device Study From Abroad: IDE Sponsorship Options Compared

The Rule That Shapes Everything: Non-US Companies Cannot Sponsor an IDE Directly

Before your non-US medical device company plans a US pivotal study, there is a foundational regulatory constraint you must understand. Under 21 CFR 812.18(a), a foreign company cannot itself serve as the sponsor of an Investigational Device Exemption (IDE) study conducted in the United States. FDA requires that a US person or US legal entity accept responsibility for the IDE application, all sponsor obligations under 21 CFR Part 812, and direct accountability to the Agency. This single rule drives every strategic decision that follows.

Three Paths Forward: A Quick Map

Non-US device manufacturers pursuing a US IDE study have three practical options: establish a US subsidiary that acts as sponsor, engage a US physician as sponsor investigator under 21 CFR 812.3(o), or contract a US sponsor of record service to hold the IDE and fulfill all regulatory obligations on your behalf. Each path carries different cost profiles, timelines, control levels, and risk postures. Choosing correctly at the outset can save months of rework and protect your pre-market pathway.

Option 1: Establish a US Subsidiary as IDE Sponsor

Forming a US legal entity, typically a Delaware or California corporation, that employs at least one US-based regulatory affairs professional is the highest-control structure available. The subsidiary signs the IDE application, accepts all sponsor duties under 21 CFR Part 812, and communicates directly with FDA as a domestic company. This structure is well suited to companies planning a long-term US commercial presence, because the infrastructure built for the IDE program carries forward into 510(k), PMA, or De Novo submissions and eventual post-market obligations.

The tradeoff is front-loaded investment. Incorporating, hiring or contracting US staff, establishing quality system procedures aligned with 21 CFR Part 820, and maintaining a US office address all require capital before a single patient is enrolled. For a company at seed stage running its first feasibility study, this structure may be premature. For a Series B company with a clear US launch roadmap, it is often the right long-term move. Your regulatory counsel should assess the corporate structure alongside your IP holding strategy, since the two are often intertwined.

Option 2: A US Physician Acting as Sponsor Investigator Under 21 CFR 812.3(o)

FDA regulations permit a single individual to hold both the sponsor and investigator roles simultaneously. Under 21 CFR 812.3(o), a sponsor investigator is defined as 'an individual who both initiates and actually conducts an investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject.' In practice, this means a US physician at an academic medical center or independent research site submits the IDE in their own name, accepts all sponsor obligations, and personally oversees device use on study participants.

This path is genuinely useful in a narrow but important scenario: a single-site, investigator-initiated feasibility or proof-of-concept study where the physician has independent scientific interest in your device and is willing to accept the regulatory burden. Many non-US manufacturers have successfully used this structure to generate early US clinical data through an academic collaborator before committing to a full IDE program.

However, be direct with yourself about the limitations. A sponsor investigator arrangement is not appropriate for a multi-site pivotal study designed to support a PMA or De Novo submission. Managing ten or twenty investigational sites, filing IDE annual reports, handling adverse device effects reporting, and coordinating a data safety monitoring board requires organizational infrastructure that a single physician cannot realistically maintain alongside a clinical practice. Asking an academic collaborator to carry that burden is both impractical and unfair. For any program of meaningful scale, this path should be taken off the table early.

Option 3: A Contracted US Sponsor of Record

The most operationally efficient path for most non-US device companies is contracting a qualified US regulatory services firm to serve as sponsor of record for the IDE. The contracted entity signs the IDE application, accepts all obligations under 21 CFR Part 812, interfaces with FDA as the responsible US party, and works in close coordination with your team on protocol design, investigational plan preparation, adverse event reporting, and site oversight.

This structure gives your company full access to the US clinical trial system without the overhead of a US subsidiary. It is particularly well matched to companies that need to move quickly, have a defined study scope, and want to preserve capital for device development rather than corporate infrastructure. A qualified sponsor of record service will also help you assess whether your study qualifies as a nonsignificant risk study under 21 CFR 812.2(b), which can eliminate the need for a full IDE application entirely and allow abbreviated requirements through an Institutional Review Board alone.

At ADB Consulting and CRO Inc., we serve as the contracted US Sponsor of Record for non-US medical device companies seeking to conduct FDA-regulated clinical studies in the United States, managing all IDE obligations so your team can focus on the science. You can review the full scope of this service at adbccro.com/us-sponsor and explore our broader clinical trial support capabilities at adbccro.com/clinical-trial-services.

Choosing the Right Path: A Practical Framework

• US Subsidiary: Best for companies with a confirmed US commercial strategy, Series B or later funding, and appetite for long-term infrastructure investment.
• Sponsor Investigator: Best for a single site, investigator-initiated feasibility study with a willing academic partner. Not appropriate for multi-site or pivotal programs.
• Contracted US Sponsor of Record: Best for non-US manufacturers that need to access the US IDE system efficiently, preserve capital, and move on a defined timeline without building a domestic legal entity first.

Before committing to any structure, your regulatory team should review the full scope of your clinical program, including number of sites, study phase, device risk classification, and anticipated post-market pathway. The structure you choose for the IDE will shape your regulatory relationship with FDA well beyond the study itself.

Ready to Assess Your US Study Strategy?

If your company is preparing to bring a device study to the United States and needs a qualified US regulatory partner to serve as sponsor of record, review study feasibility, or prepare your IDE application, the ADB team is ready to help. Book a free discovery call with Andre Butler and the ADB regulatory team at adbccro.com/clinical-trial-services to discuss your program and identify the right path forward.

Reviewed October 21, 2026 by ADB's regulatory team.

Frequently Asked Questions

Can a non-US company submit an IDE application directly to FDA?

No. Under 21 CFR 812.18(a), a foreign company cannot serve as the IDE sponsor. A US person or US legal entity must accept all sponsor obligations. Non-US manufacturers must use one of the three structures described above: a US subsidiary, a US physician sponsor investigator, or a contracted US sponsor of record.

What is a nonsignificant risk device study and does it still require an IDE?

A nonsignificant risk study involves a device that does not present a significant risk to participants as defined under 21 CFR 812.3(m). These studies are not exempt from IDE regulations entirely, but they qualify for abbreviated requirements under 21 CFR 812.2(b), meaning IRB approval and informed consent are required but a formal IDE application to FDA is not. Your regulatory team should carefully assess your device and protocol against the nonsignificant risk criteria before making this determination.

How long does it take FDA to review a full IDE application?

FDA has 30 days to review an IDE application after receipt under 21 CFR 812.30(a). In practice, FDA may issue additional information requests or put the application on clinical hold, which can extend the timeline. Preparing a thorough, well-organized IDE submission that anticipates likely FDA questions is the most effective way to keep the review process on track. ADB's team can help you prepare and review your IDE package before submission.

If this applies to your program, our US Sponsor of Record service walks through the process in detail.