IDE Sponsor and Nonsoftware Ownership Map¶
| Field | Value |
|---|---|
| Status | Gap and ownership map; does not assert completion |
| Regulatory basis | 21 CFR 812.20 and 812.25; FDA IDE application guidance |
| Date | 2026-09-04 |
Purpose¶
This map distinguishes the engineering-owned software package from sponsor,
clinical, site, data-management, manufacturing, monitoring, and regulatory
materials needed for a complete IDE. Not identified in controlled software records means that
the software package does not contain controlled evidence of completion;
it does not mean the artifact does not exist elsewhere.
Ownership Map¶
| IDE element | Primary owner | Expected source artifact | Current status | Controlled software evidence | Missing evidence or decision |
|---|---|---|---|---|---|
| Sponsor identity and correspondence | Sponsor/Regulatory | IDE cover letter, sponsor contact, correspondence authority | Not identified in controlled software records | None identified | Controlled sponsor/correspondent record |
| Report of prior investigations | Sponsor with Clinical/Engineering | Comprehensive clinical, animal, laboratory, adverse, and publication report | Software portion available; complete report not evidenced | Software Prior Testing Summary; formal software evidence | Nonsoftware and clinical prior-investigation package; GLP statements where applicable |
| Investigational-plan purpose and duration | Sponsor/Clinical | Approved investigational plan | Final Protocol Version 1.0 dated 1 September 2026 reviewed for software consistency | Software consistency crosswalk; Software Submission Core | Nonsoftware submission administration is outside this software map |
| Clinical protocol and analysis | Clinical PI/Protocol lead, Biostatistics | Approved protocol, statistical analysis, case-report forms | Final protocol is materially consistent with Build 843 | Software consistency crosswalk | Statistical and CRF package are outside the software package |
| Comprehensive risk analysis and risk minimization | Sponsor/Clinical with Engineering and sponsor-designated review approver | Clinical and device risk analysis | Software risk analysis available; complete IDE risk package not evidenced | Risk Analysis, human-factors summary, anomaly register | Sponsor residual-risk acceptance and nonsoftware/clinical risk integration |
| Device description and anticipated changes | Engineering, Device/Manufacturing, Sponsor | Complete device description and principles of operation | Software description available; complete device package not evidenced | Software Submission Core; SDD | Hardware, accessories, supplier device descriptions, anticipated change plan |
| Monitoring procedures and monitor identity | Sponsor/Clinical Operations | Monitoring plan, monitor names/addresses, escalation and source-data review | Not identified in controlled software records | Protocol references monitoring generally | Controlled monitoring plan and assigned monitors |
| Additional study records and reports | Sponsor/Data Management/Clinical Operations | Record/report inventory beyond 21 CFR 812 Subpart G | Partially described; controlled inventory not identified | Protocol data sections; telemetry scope decision | Data-management plan, source-of-truth decisions, report schedule |
| Manufacturing, processing, packing, storage, installation controls | Manufacturer/Sponsor with designated review approver | Manufacturing and device-control description | Not identified in controlled software records | Software configuration identification only | Device manufacturing, packaging, storage, installation and quality controls |
| Device accountability and distribution | Sponsor/Clinical Operations/Sites | Shipment, custody, assignment, return, destruction, version-to-subject records | Software version-to-subject requirement defined; execution records not identified | Change-control procedure; app telemetry concepts | Controlled accountability logs and site procedures |
| Investigator agreements, qualifications, and list | Sponsor/Clinical Operations | Signed agreements, CVs, financial disclosure, investigator list | Not identified in controlled software records | None identified | Complete signed investigator package |
| IRB information and approval | Sponsor/Sites/IRB | IRB list, chairpersons, submissions, approvals, continuing review | Not identified in controlled software records | None identified | Controlled IRB approvals and correspondence |
| Other participating institutions | Sponsor/Clinical Operations | Institution list and responsibilities | Not identified in controlled software records | Protocol identifies MGB context | Controlled complete site/institution list |
| Device charges/commercialization statement | Sponsor/Finance/Regulatory | Charge statement and noncommercialization rationale | Not identified in controlled software records | None identified | Sponsor decision and submission content |
| Labeling | Sponsor/Regulatory/Clinical with Engineering and designated review approver | 21 CFR 812.5 labeling, IFU, device labels, warnings | IFU-BL-001 revision 1.17 and synchronized final device labeling are approved and verified | IFU-BL-001 revision 1.17; September 2026 approval record; synchronized 008_Device_Labeling.pdf; app investigational banner; software consistency crosswalk |
Assemble the controlled label and IFU attachments in the final submission |
| Informed consent and participant materials | Sponsor/Clinical/IRB | Approved consent and all participant-facing materials | Final consent software disclosure is consistent with Build 843 | Software consistency crosswalk | General consent and IRB administration are outside the software package |
| Training | Clinical Operations/Sites | Trainer qualifications, curriculum, competency and completion records | Procedure described; controlled records not identified | Protocol training text; IFU | Approved curriculum, competency criteria, completed records |
| Clinical data management | Data Management/Biostatistics/Sponsor | Data-management plan, data sources, reconciliation, retention, analysis transfer | Official sources identified: Dexcom Clarity for CGM outcomes, BionicLoop exported CSV for insulin-delivery outcomes; Scout supportive/optional | 2026-08-27 and 2026-08-31 clinical approval record; protocol data sections; local protected evidence and recovery export; Scout support controls | Database controls, reconciliation, retention, analysis-transfer plan, and controlled incorporation into protocol/data-management documents |
| Safety and progress reporting | Sponsor/Medical Monitor/Clinical Operations | UADE, deviation, progress, final, IRB, and FDA report procedures | EDC/eCRF identified as the official safety-event record; proposed wording allows participant report/assessment and medical-record review as source information, with investigator causality/relatedness determination; operational procedure remains pending | 2026-08-27 and 2026-08-31 clinical correspondence; software alert/evidence records | Controlled reporting procedures, owners, timelines, EDC/eCRF controls, causality/relatedness process, and completed reports |
| Clinical monitoring and medical oversight | Medical Monitor/Clinical lead | Safety monitoring, escalation, review and stopping procedures | Partly described in protocol; controlled operational package not identified | Protocol source | Approved monitoring and medical-oversight records |
| Environmental categorical exclusion and other FDA-requested information | Sponsor/Regulatory | Applicable submission statement and requested information | Not identified in controlled software records | None identified | Regulatory determination and submission content |
Submission Control¶
The sponsor/Regulatory lead owns the final IDE completeness assessment. The software package closes only the engineering-owned portion and must not be used to infer completion of nonsoftware elements.
Primary Regulatory Sources¶
- FDA, IDE Application: https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-application
- FDA, IDE Approval Process: https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process