IDE Software Engineering Handoff - 2026-08-25¶
| Field | Value |
|---|---|
| Status | Engineering package complete; limited sponsor acceptance and document-control actions remain |
| Engineering baseline | ide-software-freeze-2026-08-21 / 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e |
| Recommended study build | BionicLoop 1.0 (843) / 1455cda7ad5d3e164b4a955ea0e3bc725a9996e9 / CC-DEV |
| Last updated | 2026-08-31 |
Purpose¶
This short handoff identifies what the Software Developer completed and the decisions the study team must make before submitting the IDE.
The Software Developer's recommendations are technical input. The sponsor's authorized representative makes and records the final decisions.
People Needed¶
The team does not need separate departments for each decision. One qualified person may perform more than one function.
| Function | Person | What this person does for this handoff |
|---|---|---|
| Sponsor or authorized sponsor representative | ________ | Makes the final submission decisions and accepts or returns the software package |
| Clinical investigator or principal investigator | ________ | Confirms clinical, protocol, IFU, and clinical-risk decisions |
| Technical reviewer, if used | ________ | Reviews software evidence and advises the sponsor; may be an external consultant |
| Regulatory preparer, if used | ________ | Assembles or submits the IDE; may be the sponsor representative or a consultant |
The study's IRB and qualified monitor remain required study functions, but they do not need to sign this software handoff.
Software Deliverables Complete¶
- frozen and identified engineering software baseline
- completed algorithm, automated app, simulation, and scoped cybersecurity execution with limitations documented
- controlled SRS, SDD, Risk Analysis, SVVP, RTM, cybersecurity, configuration, prior-testing, and evidence indexes
- concise FDA-facing Core and controlled Technical Appendices
- Build 843 source, signed archive, dependency lock, upload, installation, real-Pod use, and formative-evidence traceability
- clinical-gated local recovery ZIP reviewed as primary covered-session reconstruction evidence, with Scout telemetry classified as corroborating backup
- known anomalies, limitations, deferred scope, and open decisions documented
- clinical approval recorded for the seven software/IDE statements and official study-data/safety-report sources on 2026-08-27, followed by approval on 2026-08-31 to implement all eight software-consistency recommendations
Decisions For The Study Team¶
The sponsor representative may accept the Software Developer's recommendation or record a different decision and rationale.
| Decision | Software Developer recommendation | Who records the final decision | Record required | Engineering reopens only if |
|---|---|---|---|---|
| IDE study build | Use Build 843. It is controlled, installed, and exercised with a real Pod. Reuse unchanged evidence and rerun only evidence affected by later changes. | Sponsor representative | Selected build, source identity, and approved evidence reuse or rerun list | Another build or additional testing is requested |
| Software evidence and residual risk | Accept the completed evidence package and documented residual risks, or return a specific concern for correction. | Sponsor representative, informed by the technical reviewer if used | Acceptance, requested correction, or requested test, with rationale | A correction, rerun, or new risk control is requested |
| Controlled protocol and consent update | Incorporate the approved software-consistency changes, verify the returned controlled versions against the crosswalk, and determine the FDA/IRB change path. | Sponsor representative and document owners | Updated protocol/consent versions, completed acceptance checklist, and change classification | Revised wording conflicts with implemented behavior |
| IFU and labeling | Designate the build and IFU, complete the approved software-labeling set, and approve the controlled documents. | Clinical investigator and sponsor representative | Approved versions, label/screen specimens, and controlled approval reference | Software, screenshots, wording, or testing must change |
| Remaining nonsoftware IDE content | Complete the protocol, monitoring, IRB, consent, investigator, device-accountability, and study-data records outside this software repository. | Sponsor representative and assigned study personnel | Completed documents, approvals, and submission location | A software inconsistency is identified |
Reopen Rule¶
Engineering reopens only when a study-team decision requests a software change, test, evidence correction, or controlled-document update. Submission assembly, approval mechanics, and signatures do not reopen the software baseline.
Decisions Already Recorded¶
Camille Powe, MD's 2026-08-27 correspondence approved the first-step Dexcom requirement, non-synthesized CGM-gap behavior, investigational Clinical Settings access model, supportive Scout role, physical-use and human-factors claim boundaries, and the distinct fingerstick mode. Official outcomes are sourced from Dexcom Clarity and the BionicLoop exported CSV; adverse events and other safety information are recorded in staff-entered electronic CRFs. Her 2026-08-31 follow-up approved implementation of all eight software-consistency recommendations, including target, meal-setting, weight, reset, G7, testing, data-source, consent, and labeling directions. These clinical directions are not open study-team decisions.
Handoff Record¶
| Field | Entry |
|---|---|
| Software package received by sponsor representative | ______ |
| Date received | ______ |
| Package accepted or returned with specific actions | Accepted / Returned |
| Signature or controlled approval reference | ______ |