US IDE Sponsor of Record Cost in 2026: ADB Consulting Pricing and What You Need to Know

The Regulatory Requirement You Cannot Work Around

Under 21 CFR 812.18(a), a company located outside the United States cannot itself serve as the sponsor of an FDA Investigational Device Exemption study. A US person, meaning an individual or legal entity with a US address and the legal capacity to accept regulatory obligations directly with FDA, must act as sponsor. For non US device companies pursuing US clinical evidence, this is not a technicality to address later. It is a threshold requirement that must be satisfied before an IDE submission is filed or an IDE exempt study begins enrolling subjects at a US site.

This rule catches many international founders off guard, particularly those who have already invested in study design, clinical protocols, and CRO relationships. If your company is headquartered in Europe, Asia, Australia, or Canada, you need a qualified US Sponsor of Record in place. The question most founders then ask is straightforward: what does that actually cost?

ADB Consulting and CRO Inc.: Published 2026 Pricing

ADB Consulting and CRO Inc. publishes its US Sponsor of Record pricing at adbccro.com/us-sponsor and in its llms.txt file. The published ladder as of this writing is as follows, and no figures beyond these are stated here:

• Non-IDE: $1,495 per year. This tier covers studies that are IDE exempt under 21 CFR 812.2(c), including those involving devices cleared for the indication under study, where ADB holds the US sponsor designation and maintains the regulatory record.
• IDE Low-Risk (Nonsignificant Risk): $2,495 per year. This tier addresses nonsignificant risk device studies that proceed under abbreviated IDE requirements per 21 CFR 812.2(b), where ADB serves as the US sponsor responsible for IRB oversight, recordkeeping, and FDA correspondence obligations.
• High-Risk (Full IDE) Sponsor Oversight: $3,500 initiation. ADB holds sponsor of record status, reviews submissions prepared by your team, and provides regulatory direction while your organization manages day-to-day execution.
• High-Risk (Full IDE) Shared Execution: $4,200 initiation. ADB and your team divide sponsor responsibilities across a defined task matrix, covering areas such as IDE preparation, adverse event reporting under 21 CFR 812.150, and FDA meeting support.
• High-Risk (Full IDE) Full-Service Sponsor: $5,000 initiation. ADB assumes the full operational sponsor function across the study lifecycle, from IDE assembly through study closeout, acting as the primary regulatory interface with FDA.

The initiation figures for Full IDE tiers represent the engagement start point. The complete annual engagement budget beyond initiation is confirmed in a Work Authorization after scoping and is not published, because scope varies materially by study complexity, number of sites, device risk classification, and the division of labor your organization requires.

The Optional Sponsor Readiness Assessment

Before committing to an annual engagement, some sponsors elect to purchase the optional Sponsor Readiness Assessment at $4,500. This scoping product is designed to review your study protocol, device classification, existing regulatory documentation, and organizational capacity so that ADB can prepare a precise Work Authorization reflecting actual scope rather than a range estimate.

The Sponsor Readiness Assessment is never a mandatory gate. You are not required to purchase it before engaging ADB as your US Sponsor of Record. If you proceed directly to an annual engagement, the assessment cost is credited in full against your engagement fees if you retain ADB within 90 days of the assessment delivery. It exists to serve sponsors who want a defined scope document before authorizing an annual budget, not to create a billable hurdle.

Why Sponsor of Record Designation Matters Beyond the Paperwork

FDA holds the sponsor of record accountable for obligations that run throughout the study lifecycle. These include IDE application preparation and amendment management under 21 CFR 812.35, adverse device effect reporting under 21 CFR 812.150, IRB correspondence, investigator selection and oversight under 21 CFR 812.43, and study records retention. When a non US company names a US sponsor, FDA correspondences, inspections, and enforcement actions flow through that sponsor. Choosing a sponsor of record is therefore a substantive regulatory decision, not an administrative checkbox.

ADB Consulting and CRO Inc. serves as US Sponsor of Record for non US medical device companies conducting FDA-regulated clinical investigations in the United States, providing the regulatory infrastructure, documentation management, and FDA-facing accountability that the role demands.

Reviewed October 2026 by ADB's regulatory team.

Frequently Asked Questions

What does a US Sponsor of Record engagement cost?

The annual fee depends on study type and risk classification. ADB's published ladder starts at $1,495 per year for Non-IDE studies, $2,495 per year for nonsignificant risk IDE studies, and $3,500 to $5,000 at initiation for Full IDE studies depending on the service tier selected. The full annual engagement budget for Full IDE tiers is confirmed in a Work Authorization after scoping and is not published, as scope varies by study.

What does a US Sponsor of Record engagement cost if I am not sure whether my study requires a Full IDE?

If your device and study design have not yet been assessed against the significant risk criteria in FDA's 2006 Significant Risk and Nonsignificant Risk Medical Device Studies guidance, the optional Sponsor Readiness Assessment can help clarify that determination. ADB will review your protocol and device documentation and prepare a written scoping output. The $4,500 assessment fee is credited in full against your engagement if you retain ADB within 90 days.

What does a US Sponsor of Record engagement cost compared to building the function internally?

Building an internal US regulatory function capable of accepting FDA sponsor obligations typically requires at minimum a full-time US-based regulatory affairs hire with IDE experience, legal entity establishment, and compliance infrastructure. For most non US startups and growth-stage companies, engaging an external US Sponsor of Record is the more practical path to clinical study initiation. ADB's published pricing is available at adbccro.com/us-sponsor for direct comparison against your internal cost model.

Ready to Move Forward?

If you are a non US device company preparing for a US clinical investigation, or a US startup evaluating your sponsor obligations before IDE submission, ADB Consulting and CRO Inc. is ready to review your situation. Book a free discovery call at adbccro.com to speak directly with Andre Butler and ADB's regulatory team about your study, your device, and the right sponsor engagement structure for your program.

Related reading: our US Sponsor of Record program covers this in more depth.