IDE Software Handoff Index
Status: Final draft prepared for handoff (pending review) Owner: BionicLoop engineering Last updated: 2026-04-07 12:32 EDT
1. Purpose
Define the exact engineering-owned software deliverable set prepared for the current IDE handoff package.
This index is not the final submission assembly. It is the package manifest that the receiving quality/submission team can use to review, approve, freeze, and incorporate into the broader IDE submission workflow.
The current packet structure and scope are recorded in IDE_Software_Packet/IDE_Software_Scope_and_Deferred_Items.md and IDE_Software_Packet/IDE_Software_Baseline_Overview.md.
The default reviewer-facing entry point for the current packet is IDE_Software_Packet/README.md.
2. Candidate FDA-Facing Software Content
The following are the core software documents and summaries that are appropriate to treat as the candidate external review set:
- IDE_Software_Packet/IDE_Software_Baseline_Overview.md
- IDE_Software_Packet/IDE_Software_Scope_and_Deferred_Items.md
- IDE_Software_Packet/IDE_Software_Risk_and_Cybersecurity_Summary.md
- IDE_Software_Packet/IDE_Software_Prior_Testing_Summary.md
- IDE_Software_Packet/IDE_Software_Verification_Summary.md
- RiskAnalysis.md
- SoftwareRequirementsSpecification.md
- SoftwareDesignDescription.md
- SoftwareVerificationAndValidationPlan.md
- TraceabilityMatrix.md
- CybersecurityPlan.md
- IFU/BionicLoop_IFU_v1.4.md
Internal handoff, freeze-planning, and coordination documents are listed below for completeness but are not intended to be the first external review set.
3. Included Engineering-Owned Deliverables
| Document | Current State | Role in Package |
|---|---|---|
| IDE_Software_Packet/README.md | Submission-prep review packet | Default reviewer entry point for the IDE software packet |
| IDE_Software_Packet/IDE_Software_Handoff_Memo.md | Internal handoff memo | One-page internal handoff note for the packet |
| IDE_Software_Packet/IDE_Receiving_Team_Freeze_Disposition_Memo.md | Internal freeze disposition memo | Freeze-time decision sheet for internal scope, evidence, and acceptance calls |
| IDE_Software_Packet/IDE_Freeze_Command_Sheets.md | Internal freeze runbook | Exact freeze-run commands for STP-ALG-001, STP-AUTO-001, and TV-SEC-001 |
| IDE_Software_Packet/IDE_Software_Baseline_Overview.md | Reviewer summary | Concise software/device baseline overview |
| IDE_Software_Packet/IDE_Software_Scope_and_Deferred_Items.md | Reviewer summary | Scope/defer review memo for the packet |
| IDE_Software_Packet/IDE_Software_Risk_and_Cybersecurity_Summary.md | Reviewer summary | Study-facing risk and cybersecurity summary |
| IDE_Software_Packet/IDE_Software_Prior_Testing_Summary.md | Reviewer summary | Concise prior-testing summary for the accepted IDE baseline |
| IDE_Software_Packet/IDE_Software_Verification_Summary.md | Reviewer summary | Concise verification posture and freeze-time needs summary |
| IDE_Software_Packet/IDE_RTM_Audit_Summary.md | Internal audit summary | Reviewer-facing RTM bucket audit for the packet |
| IDE_Software_Packet/IDE_Formal_Evidence_Execution_Plan.md | Internal freeze execution plan | Formal evidence execution plan for freeze of the current packet |
| RiskAnalysis.md | Final draft prepared for handoff | Software hazard/control baseline |
| SoftwareRequirementsSpecification.md | Final draft prepared for handoff | Controlled software requirements |
| SoftwareDesignDescription.md | Final draft prepared for handoff | Design allocation and software behavior description |
| SoftwareVerificationAndValidationPlan.md | Final draft prepared for handoff | Verification inventory and strategy |
| TraceabilityMatrix.md | Final draft prepared for handoff | RA -> SRS -> SDD -> TV -> evidence chain |
| CybersecurityPlan.md | Final draft prepared for handoff | In-scope software security controls and deferred auth/cloud boundary |
| Cybersecurity_Handoff_Register.md | Active working register | Cybersecurity artifact, provenance, and inherited-control tracking for the handoff package |
| Cybersecurity_SOUP_Provenance_Review.md | Active working review | Repo-observable provenance baseline for embedded local packages |
| Cybersecurity_Embedded_Package_Delta_Review.md | Active working review | Curated security-relevant local-delta review for embedded LoopKit, G7SensorKit, and OmniBLE packages |
| Cybersecurity_Local_File_and_Permission_Review.md | Active working review | File/export/permission review note supporting RA-009 and TV-SEC-001 scope |
| Cybersecurity_Dependency_Inventory.md | Active working inventory | Current dependency snapshot for embedded/local/binary/remote software composition |
| Cybersecurity_SBOM_and_Advisory_Process.md | Active working process note | Freeze-time SBOM generation and advisory-review ownership/process for the software handoff package |
| Cybersecurity_Logging_and_Secret_Review.md | Active working review | Focused auth/network/telemetry logging and secret-redaction review note |
| Cybersecurity_Supplier_Artifact_Request_List.md | Active working handoff note | Prepared request matrix for external DASH/G7/Dexcom-app inherited-control artifacts |
| Cybersecurity_Baseline_Acceptability_Recommendation.md | Active working recommendation | Engineering recommendation for investigational-vs-production acceptability of the current local export/file-sharing/logging posture |
| Cybersecurity_TV_SEC_001_Freeze_Execution_Checklist.md | Active working checklist | Freeze-time evidence recipe for in-scope TV-SEC-001 export/file-handling verification |
| DevelopmentSOP.md | Final draft prepared for handoff | Engineering process / quality gates |
| STP/README.md | Final draft prepared for handoff | STP package index |
| STP/STP-ALG-001.md | Final draft prepared for handoff | Algo protocol owner |
| STP/STP-AUTO-001.md | Final draft prepared for handoff | Automated protocol owner |
| STP/STP-SIM-001.md | Final draft prepared for handoff | Simulation protocol owner |
| STP/STP-HW-001.md | Final draft prepared for handoff | Hardware protocol owner |
| STP/STP-ALERT-001.md | Final draft prepared for handoff | Alert drill protocol owner |
| STP/STP-TV-Ownership-Map.md | Final draft prepared for handoff | TV-* ownership / deferred mapping |
| STP/STR-Execution-and-Reporting-Guide.md | Final draft prepared for handoff | STR execution governance |
| CodeReviewLog.md | Active controlled log | Commit-level review trace |
| IFU/BionicLoop_IFU_v1.4.md | Current engineering review draft | Software-facing IFU narrative |
| IFU/BionicLoop_IFU_v1.4.pdf | Current engineering review PDF | IFU review package |
| IDE_Submission_Readiness_Report.md | Working draft | Handoff blocker and closure sequence report |
| IDE_Baseline_Freeze_Plan.md | Working draft | Freeze sequencing and gate plan |
| IDE_Submission_Closure_Checklist.md | Active working checklist | Engineering closure checklist |
| IDE_Software_Handoff_Disposition_Log.md | Active working log | Accepted / deferred scope decisions |
| ## 4. Included Evidence Structure |
| Evidence Path | Current Role |
|---|---|
Docs/Quality/Evidence/Formal/ |
Intended claimed closure lane for formal STR evidence |
Docs/Quality/Evidence/Formal/STR-README-Template.md |
Shared README authoring template for formal STR bundles |
Docs/Quality/Evidence/Formal/STR-ALG-001/ |
Prepared formal shell for the algorithm evidence bundle |
Docs/Quality/Evidence/Formal/STR-AUTO-001/ |
Prepared formal shell for the automated freeze bundle |
Docs/Quality/Evidence/Formal/STR-SEC-001/ |
Prepared formal shell for the TV-SEC-001 evidence bundle |
Docs/Quality/Evidence/Working/ |
Development support lane only; not final claimed closure evidence for handoff |
5. Explicitly Deferred or Non-Owned Items
| Topic | Current Disposition |
|---|---|
| Formal review / approval signatures | Not engineering-owned in this pass |
| Final IDE submission assembly | Not engineering-owned in this pass |
| Residual-risk acceptance signoff | Not engineering-owned in this pass |
| Cloud / device-to-cloud verification closure | Deferred from current software handoff package |
| Part 11 package closure | Deferred from current software handoff package |
| Supplier / manufacturing / training / non-software QMS artifacts | Not engineering-owned in this pass |
6. Current Package Use
Use this index together with:
- IDE_Submission_Readiness_Report.md
- IDE_Submission_Closure_Checklist.md
- IDE_Software_Handoff_Disposition_Log.md
Current expectation:
- engineering prepares this package to a handoff-ready state
- the receiving quality/submission team performs formal review, approval completion, freeze ownership, and final release assembly