Regulatory dossier map · development v0.1

AIRCHILL EU & FDA Clinical Submission Package

This page converts the AIRCHILL clinical programme into a submission checklist. It is a planning dossier map, not legal advice and not an authority-approved classification or submission.

EU / MDR pathway

For a conformity-oriented clinical investigation, the working framework is MDR Article 62 together with Articles 63–80 and Annex XV. The application under Article 70 must be accompanied by the documentation required by Annex XV Chapter II.

A. Administrative / application layer

• Sponsor and legal representative information where applicable.
• Clinical investigation title, protocol/CIP code, version/date and investigation identifiers.
• Member State/site/investigator list.
• Application/notification forms and EUDAMED/CIV-ID/SIN information as applicable to the submission route in force.
• Proof of insurance/indemnity and financial arrangements where required.
• Ethics documentation and country-specific participant-facing materials.

B. Core scientific dossier

• Clinical Investigation Plan: AIRCHILL-CA or AIRCHILL-STROKE full CIP, aligned to MDCG 2024-3.
• Investigator’s Brochure: populated AIRCHILL IB aligned to MDR Annex XV and MDCG 2024-5.
• Clinical investigation synopsis in the official Union language required by the Member State.
• Scientific rationale / state-of-the-art evidence and clinical evaluation link.
• Statistical Analysis Plan or sufficiently complete statistical section plus controlled SAP reference.
• Schedule of Assessments and CRFs/eCRF specification.

C. Device / technical package

• Device description, intended purpose and current configuration.
• Manufacturing information sufficient for investigational use assessment.
• Essential performance and bench verification relevant to the investigation.
• Risk-management file / benefit-risk summary.
• Biocompatibility, electrical safety, EMC, software/cybersecurity, usability/human factors and gas-path testing as applicable.
• Preclinical large-animal airway/physiology evidence.
• Investigational labels, IFU and training materials.

D. Participant protection

• Patient information/informed consent or legally permitted emergency/deferred-consent documents.
• Data protection/privacy notices.
• Compensation/insurance.
• Recruitment/screening material.
• Independent DSMB Charter.

E. Conduct / safety

• Monitoring plan and site qualification process.
• AE/SAE/device deficiency safety-reporting plan.
• Device accountability and deficiency handling.
• Protocol deviation/CAPA process.
• Trial Master File document index.

EU pre-submission questions to resolve

1. Confirm intended clinical-investigation route and authority/ethics submission sequence for target Member States.
2. Confirm whether the staged operating envelope and human airway-safety evidence are sufficient for first emergency-patient use.
3. Confirm clinical endpoint and sample-size strategy for the intended clinical benefit claim.
4. Agree emergency/deferred-consent approach per jurisdiction.
5. Confirm what constitutes a substantial modification when temperature range, gas-path components, software or study population changes.

USA / FDA pathway

AIRCHILL should be planned on the assumption that a patient-interventional study of an investigational life-supporting ventilation/cooling device may be considered a Significant Risk device study. Final determination belongs to FDA/IRB. A Significant Risk study requires FDA IDE approval and IRB approval before enrolment.

A. Pre-Submission / Q-Submission first

Before an IDE, request focused FDA feedback on the development pathway. A Pre-Sub should contain:

• Device description and intended use.
• Current engineering/preclinical evidence.
• Risk analysis and operating envelope.
• Proposed early-feasibility and later pivotal clinical design.
• Specific questions rather than a generic request for review.

Recommended FDA questions

1. Does FDA agree that the proposed staged airway-safety and early-feasibility package is adequate before OHCA/EVT enrolment?
2. Does FDA agree with the proposed study-risk determination and IDE pathway?
3. Are the proposed respiratory thermal-dose limits and stop rules sufficient?
4. Does FDA agree with the CA neurological and stroke ordinal-mRS primary endpoints for a later pivotal claim?
5. What non-clinical ventilation, gas-delivery, software, electrical, biocompatibility, usability and transport testing must be complete before IDE?
6. Is the proposed adaptive/blinded sample-size re-estimation strategy acceptable?

B. IDE application structure

• Cover letter and administrative information.
• Report of prior investigations.
• Investigational plan / clinical protocol.
• Device description and manufacturing information.
• Investigator agreements / site information as required.
• IRB information and informed consent materials.
• Labeling for investigational use.
• Environmental assessment/exclusion where applicable.
• Monitoring procedures.
• Additional information requested by FDA.

C. Early Feasibility Study strategy

CA-1/ST-1 can be framed as limited early feasibility investigations if FDA agrees: small subject numbers, initial clinical safety/functionality, controlled device iteration and stringent subject protection. Device modifications during an EFS require the specific IDE change-management process.

D. Electronic submission tooling

FDA’s eSTAR programme now includes PreSTAR tools for several early-submission/Q-Submission use cases. Use the current FDA-supported template available at the time of submission; do not lock the AIRCHILL dossier to a draft electronic-template requirement until FDA finalises it.

Gap register before any submission

Controlled dossier index

CA CIP · Stroke CIP · IB · SAP · SoA/CRF · DSMB · Monitoring · Safety

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