21 CFR Part 812 · Investigational Device Exemption
21 CFR Part 812 requires every IDE study to have a designated sponsor who answers to FDA for the full obligation set. A foreign manufacturer without US operations cannot easily carry that accountability — ADB serves as sponsor-of-record, holding the regulatory relationship with FDA while the execution split is agreed in writing before the study begins.
Request Your Readiness AssessmentRegulatory Accountability
IDE Application Ownership & Amendments
21 CFR 812.20 · 812.35FDA Correspondence & Agency Liaison
21 CFR 812.40(a)Investigator Selection & Signed Agreements
21 CFR 812.43Monitoring & Securing Investigator Compliance
21 CFR 812.40 · 812.46(a)Unanticipated Adverse Device Effect Evaluation & Reporting
21 CFR 812.46(b) · 812.150(b)(1)Records & Reports to FDA
21 CFR 812.140 · 812.150IRB Coordination & Review Status
21 CFR 812.42 · 812.40Device Shipment & Import Under IDE Provisions
21 CFR 812.18Prohibition on Promotion & Commercialization of Investigational Devices
21 CFR 812.7Engagement Structure
ADB holds the sponsor-of-record designation in every level. The levels describe how execution is divided between ADB and your team. Which level fits depends on your clinical operations capacity — the Readiness Assessment determines that.
Sponsor Oversight
ADB holds the sponsor-of-record and directs regulatory oversight. Your established clinical operations team executes site management and logistics under ADB's SOPs, monitoring plan, and review. ADB reviews all study documentation and maintains the regulatory record.
Shared Execution
ADB is sponsor-of-record and executes the regulatory critical path: IDE submission and amendments, monitoring plan development, safety reporting workflows, and FDA correspondence. Your team manages site operations, investigator logistics, and data flow.
Full-Service Sponsor
ADB executes from IDE strategy through study close-out: protocol support, IDE submission, investigator agreements, monitoring, safety reporting, records management, and FDA communications. Your team focuses on the science and device.
How Engagement Works
No scope ambiguity, no surprise fees, no guesswork on regulatory accountability.
Sponsor Readiness Assessment
Fixed-fee structured review of your study against the Part 812 obligation set. Scheduled within days of your inquiry. Delivered as a written gap report.
Gap Report + Recommended Level + Fixed Budget
Written delivery: identified gaps and remediation items, recommended engagement level with rationale, and a fixed proposed budget for your study. No hourly-billing surprises.
Engagement Under Master Agreement
Engagement proceeds under a master consulting agreement with defined scope, execution split, and deliverables. ADB assumes the sponsor-of-record designation from day one.
You will know exactly what FDA will hold the sponsor accountable for, exactly who is doing what, and exactly what it costs — before you commit to the engagement.
The Entry Product
One flat fee. Written deliverables. Full credit toward your engagement.
flat fee · written deliverables · engagement credit included
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Tell us about your device and study. You'll hear from me within one business day to schedule your assessment call.
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Common Questions
When an investigational device is imported to the US for clinical investigation, 21 CFR 812.18 requires the sponsor to satisfy FDA import and labeling requirements. More broadly, the full Part 812 obligation set — IDE application, FDA correspondence, investigator agreements, monitoring, and safety reporting — requires a sponsor with US presence capable of interfacing with FDA in real time. Foreign companies without US operations face significant practical and regulatory barriers to managing that obligation set directly. ADB serves as the US-based sponsor of record, carrying the statutory accountability while aligning execution with your team by agreement.
The sponsor of record owns every obligation in 21 CFR Part 812: the IDE application and all amendments, FDA correspondence and agency liaison, investigator selection and signed agreements, monitoring and securing compliance, unanticipated adverse device effect evaluation and reporting, records and reports, IRB coordination, device import compliance, and the prohibition on promotion or commercialization of investigational devices. These obligations attach to the sponsor by regulation — they cannot be delegated away. Whoever holds the sponsor-of-record designation answers to FDA for all of them.
FDA has 30 calendar days to approve or disapprove an IDE application under 21 CFR 812.30. In practice, FDA often responds with conditional approval — approval subject to specific modifications — rather than outright disapproval. Realistic timelines are driven by study complexity, the applicable review division's current workload, and whether the IDE package is complete at submission. Incomplete applications, protocol gaps, or insufficient preclinical data commonly trigger an IDE hold that restarts the 30-day clock. Pre-Submission meeting strategy with FDA before the IDE submission is the most reliable way to shorten real-world review time.
Engagement fees are determined by the Sponsor Readiness Assessment. The assessment produces a written gap report, a recommended engagement level, and a fixed proposed budget specific to your study. We do not publish engagement budgets because the scope differs materially from study to study — device type, risk classification, number of clinical sites, protocol complexity, and the execution split between ADB and your team all affect the fee. The $4,500 assessment fee is credited in full toward your engagement if you proceed within 90 days of assessment delivery.
The Sponsor Readiness Assessment is a flat-fee structured review of your study against the full 21 CFR Part 812 obligation set. It delivers: a readiness gap report identifying deficiencies and remediation items; a recommended engagement level (Sponsor Oversight, Shared Execution, or Full-Service Sponsor) with written rationale; and a fixed proposed budget for your sponsor engagement. The assessment fee is $4,500 and is credited in full toward your engagement if you proceed within 90 days of delivery.
Assessment calls are typically scheduled within a few business days of inquiry. The written assessment is delivered after that call. Timeline from that point depends on study readiness — IRB status, protocol completeness, preclinical data package, and whether an IDE application is already in preparation. Studies at the pre-submission planning stage have more lead time available; studies with active IDE holds may require immediate sponsor action on the clinical site compliance front.
No. A US Agent designation under 21 CFR Part 807 is a correspondence and registration service for foreign establishments that manufacture and distribute devices in the US commercial market — ADB receives FDA correspondence and manages annual establishment registration. It does not make ADB the sponsor of any clinical study and carries no Part 812 obligations whatsoever. If you need both a US Agent for your commercial device distribution and a US sponsor of record for a clinical study, those are separate engagements. US Agent service is available on our FDA Device Registration page at $595 per year.
Ready to Proceed?
$4,500 flat fee · Written gap report · Fixed proposed budget · Full credit toward engagement within 90 days.