The rule that shapes every IDE study: who can be a sponsor
Under 21 CFR 812.18(a), a company located outside the United States cannot itself sponsor an FDA Investigational Device Exemption (IDE) study. A US person or entity must act as the sponsor and remains fully accountable to FDA for every obligation under Part 812, regardless of what any contract research organization (CRO), distributor, or other contractor performs. This is not a procedural technicality. It is a threshold requirement, and FDA enforces it actively through its Bioresearch Monitoring (BIMO) inspection program.
What a BIMO sponsor inspection actually checks
A BIMO sponsor inspection conducted under Compliance Program 7348.810 reviews whether the sponsor has exercised adequate oversight of the entire IDE study. Investigators assess whether the sponsor selected qualified investigators, monitored study conduct, maintained complete device accountability, submitted required reports to FDA and IRBs on time, and kept records sufficient to reconstruct every critical decision made during the trial.
Why CRO delegation does not transfer regulatory responsibility for device studies
This is the point that surprises many non-US device companies and even some experienced regulatory professionals. FDA's Compliance Program 7348.810 states explicitly: 'Device regulations (21 CFR 812) do not provide for the transfer of regulatory obligations to CROs; therefore, device sponsors are held responsible for regulatory noncompliance by a CRO.' (FDA Compliance Program 7348.810, Sponsor Inspection).
It is worth noting that in other contexts, FDA guidance uses broader language describing a 'sponsor' as any entity to whom obligations have been transferred in writing. That general framing applies in certain drug and biologics contexts. For device IDE studies, it must always be read alongside the device-specific sentence above, which makes clear that no such transfer is recognized under 21 CFR 812. Presenting the general language alone, without that device-specific limitation, would create a false impression that device sponsors can delegate their Part 812 obligations to a CRO and walk away. They cannot.
What a BIMO inspector typically asks a sponsor to produce
When an FDA investigator arrives for a sponsor inspection under Compliance Program 7348.810, the document requests follow a consistent pattern. Sponsors should be prepared to present:
- IRB correspondence: Initial approvals, continuing review approvals, any adverse event or unanticipated device effect reports submitted to each IRB, and all IRB communications related to protocol amendments.
- Investigator agreements: Signed agreements with each clinical investigator under 21 CFR 812.43, including documentation that investigators were provided the investigational plan and all relevant device information before enrolling subjects.
- Monitoring records: Visit reports, remote monitoring logs, corrective action letters sent to investigators, and documentation of follow-up on any deficiencies identified during monitoring.
- Device accountability logs: Complete records tracking the shipment, use, return, and disposition of every investigational device at every site, as required under 21 CFR 812.140(b)(4).
Gaps in any of these four categories are among the most common findings cited in FDA Form 483 observations issued to device sponsors. A missing monitoring visit log or an incomplete device accountability record can quickly become the centerpiece of a warning letter.
Nonsignificant risk studies carry the same accountability standard
Some sponsors of nonsignificant risk device studies assume that because a full IDE application is not required, their oversight obligations are lighter. That assumption is incorrect. The sponsor accountability framework under Part 812, including the monitoring and recordkeeping requirements that BIMO inspectors review, applies to nonsignificant risk studies as well. The abbreviated IDE pathway reduces the submission burden; it does not reduce the sponsor's responsibility to oversee the study and maintain complete records.
What this means for non-US device companies
If your company is headquartered outside the United States and you are planning or currently running a US IDE study, you need a qualified US Sponsor of Record who understands Part 812 obligations and can produce the documentation described above on the day an FDA investigator requests it. That person or entity cannot simply hold a title on paper. FDA's BIMO inspection will assess whether genuine oversight was exercised.
ADB Consulting and CRO Inc. serves as US Sponsor of Record for non-US device companies seeking to conduct IDE studies in the United States, maintaining direct accountability to FDA and providing the structured oversight infrastructure that a BIMO inspection is designed to assess. Learn more at adbccro.com/us-sponsor, review your obligations with the US Sponsor Obligations Checklist, or use the US Sponsor Decision Tool to assess your specific situation.
If you are preparing for a BIMO inspection, reviewing your IDE sponsor file for completeness, or evaluating whether your current sponsor arrangement meets FDA's requirements, ADB's regulatory team is ready to help. Book a free discovery call at adbccro.com to speak directly with a practice director who can review your situation and help you prepare a defensible path forward.
Reviewed November 8, 2026 by ADB's regulatory team.
Frequently asked questions
Can a non-US company be listed as the sponsor on an FDA IDE application?
No. Under 21 CFR 812.18(a), only a person located in the United States may sponsor an IDE study. A non-US company must designate a US Sponsor of Record who accepts full regulatory accountability to FDA for all Part 812 obligations. That US sponsor is the entity FDA will inspect and hold responsible for any noncompliance, including noncompliance by any CRO or vendor the sponsor engages.
If we hire a CRO to run our IDE study, does the CRO become responsible for FDA compliance?
No. As FDA's Compliance Program 7348.810 states explicitly, device regulations under 21 CFR 812 do not provide for the transfer of regulatory obligations to CROs. The sponsor remains responsible for all regulatory noncompliance, including acts or omissions by the CRO. Sponsors should review their CRO contracts and oversight procedures carefully to assess whether their monitoring and recordkeeping infrastructure would hold up under a BIMO inspection.
What is the most common reason device sponsors receive FDA Form 483 observations after a BIMO inspection?
The most frequently cited deficiencies in sponsor BIMO inspections involve inadequate monitoring records, incomplete device accountability logs, and missing or untimely IRB communications. These are exactly the four document categories that FDA investigators request at the outset of a sponsor inspection. Sponsors who prepare these records systematically throughout the study are in a far stronger position to respond to inspector inquiries than those who attempt to reconstruct documentation after an inspection is announced.
If this applies to your program, our US Sponsor of Record service walks through the process in detail.
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