Pre-Submission Before the IDE for Foreign Sponsors: What to Ask FDA and Who Signs

The rule foreign device makers must understand before they touch an IDE

Under 21 CFR 812.18(a), a company outside the United States cannot itself sponsor an FDA Investigational Device Exemption study. A US person or entity must act as sponsor and bear full legal accountability for the investigation. That same principle flows directly into the Q-Submission process: the named US sponsor, not the foreign manufacturer, is the signatory FDA expects on the Pre-Submission for an IDE program and on the IDE application that follows it. Getting this wrong at the Pre-Sub stage is not a minor paperwork error. It signals to FDA that the regulatory structure of the program has not been properly established, and it can delay your entire clinical timeline.

Why a Pre-Submission matters before you file the IDE

A Pre-Submission (formerly known as a Pre-IDE) is your structured opportunity to ask FDA specific questions before you invest in a full IDE package. For programs involving foreign manufactured devices, the Pre-Sub is especially valuable because the regulatory setup is more complex than a domestic program. FDA reviewers can provide written feedback on your study design, your risk classification, and the adequacy of your proposed investigational plan before you commit to a filing strategy.

FDA's Q-Submission Program guidance states: 'The Q-Submission program is intended to facilitate communication between FDA and sponsors or applicants for the purpose of resolving questions about a regulatory submission.' That framing is important. The Pre-Sub is a communication tool, and using it well before the IDE means your questions are on record and FDA's written responses become part of your regulatory file. You can access the full guidance at FDA's Q-Submission Program Guidance page.

What a foreign manufactured device program should ask FDA in a Pre-Submission

Before filing the IDE, a foreign manufactured device program should ask FDA to assess the proposed risk classification of the device under 21 CFR 812.3(m), review whether the investigation qualifies as a nonsignificant risk or significant risk study, assess the adequacy of the proposed investigational plan and primary endpoint structure, review the acceptability of non US manufacturing and quality system documentation in support of the IDE, and assess whether any additional preclinical data will be required prior to first in human use in the United States. Presenting these questions clearly and concisely in the Pre-Sub gives your team written FDA feedback that directly informs how the IDE itself is structured and what supporting documentation to prepare.

The signatory question: who signs the Pre-Submission and the IDE

This is where many foreign sponsors make a costly mistake. The named US sponsor, not the foreign manufacturer, is the signatory FDA expects on the Pre-Submission and the IDE that follows it. The US sponsor is not a passive intermediary or a contract post office. Under 21 CFR 812.18(b), the foreign manufacturer may contribute data and device samples, but the US sponsor assumes full legal responsibility for the conduct of the investigation, compliance with IDE regulations, and all communications with FDA. When FDA issues a deficiency letter or an approval, it is addressed to the US sponsor. When an IRB has a question about the investigation, the US sponsor is the contact. The Pre-Submission is the first formal document in the IDE program record, and it must reflect this structure accurately from the start.

If your organization is still determining who should serve in this role, our US Sponsor Decision Tool can help you assess the right structure for your program. Once that decision is made, our US Sponsor Obligations Checklist walks through every regulatory responsibility the sponsor takes on under 21 CFR Part 812.

Preparing the Pre-Submission with the right sponsor structure in place

A well-prepared Pre-Sub for a foreign device IDE program will include a clear identification of the US sponsor as the submitting party, a summary of the device and its intended use, the proposed risk classification with supporting rationale, a preliminary investigational plan outline, and the specific questions you are asking FDA to review. The Pre-Sub cover letter and all correspondence should carry the name and contact information of the US sponsor, not the foreign manufacturer. This consistency across documents signals to FDA that your regulatory team understands the requirements before the IDE is ever filed.

ADB Consulting and CRO Inc. serves as US Sponsor of Record for foreign device manufacturers conducting FDA regulated clinical investigations in the United States, providing full regulatory accountability and direct FDA communication on behalf of international clients. Learn more about how we structure Pre-Submission packages for IDE programs at adbccro.com/fda-pre-sub-consulting.

Reviewed October 27, 2026 by ADB's regulatory team.

Ready to assess your Pre-Submission strategy before you file your IDE? Book a free discovery call with Andre Butler and the ADB team today.

Frequently asked questions

Can a foreign company sign and submit a Pre-Submission for an IDE program directly to FDA?

No. Under 21 CFR 812.18(a), a non US company cannot sponsor an FDA IDE study. The Pre-Submission for an IDE program must be submitted and signed by the designated US sponsor. Submitting under the foreign manufacturer's name creates a structural problem in the regulatory record that will need to be corrected before FDA accepts the IDE.

What is the difference between the foreign manufacturer and the US sponsor in an IDE program?

The foreign manufacturer designs, builds, and provides the device and its supporting technical documentation. The US sponsor is the legal entity that takes responsibility for the investigation under 21 CFR Part 812, signs all FDA submissions, communicates directly with FDA and IRBs, and is accountable for sponsor obligations throughout the study. These are distinct roles, and FDA treats them as such.

How early in a clinical program should a foreign device company file a Pre-Submission?

As early as possible, ideally before preclinical work is finalized and well before the IDE is drafted. Filing a Pre-Sub early allows your team to review FDA's written feedback and prepare an IDE that addresses any concerns identified. For foreign manufactured device programs, early Pre-Sub engagement also gives the US sponsor time to prepare the regulatory infrastructure that the IDE will require.

If this applies to your program, our Pre-Submission (Q-Sub) consulting service walks through the process in detail.