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IDE Software Handoff Disposition Log

Status: Active working log
Owner: BionicLoop engineering
Last updated: 2026-04-06 16:35 EDT

1. Purpose

Record the explicit scope and requirement dispositions used to prepare the engineering-owned IDE software handoff package.

This log is not a formal approval record. It is the engineering-side disposition source that the receiving quality/submission team can review, accept, revise, or carry forward into controlled approval workflow.

2. Package Scope Decisions

Topic Current Disposition Rationale Next Owner / Follow-up
Local app/runtime/algorithm/device software docs In scope This is the primary engineering-owned software package for IDE handoff. Engineering maintains and prepares for handoff.
STP package and software verification structure In scope Engineering owns the software protocol and evidence structure needed for downstream review. Engineering closes draft-to-handoff-ready metadata and ownership mapping.
IFU software package In scope IFU content and screenshot package are software-facing deliverables prepared by engineering. Engineering maintains current package; receiving team handles formal review workflow.
Cloud / device-to-cloud verification closure Deferred from current software handoff package Current week is focused on local software package readiness, not cloud or web-system closure. Receiving quality/submission team decides whether to re-open later.
Part 11 readiness package closure Deferred from current software handoff package Part 11 closure requires broader system and quality-process decisions beyond this software handoff slice. Receiving quality/submission team.
Formal review / approval signatures Not engineering-owned in this pass Engineering prepares metadata placeholders only. Receiving quality/submission team.
Final submission assembly / release authorization Not engineering-owned in this pass Downstream release handling is outside the engineering handoff scope. Receiving quality/submission team.

3. Requirement Dispositions

Item Current Disposition Baseline Decision Rationale Follow-up
SRS-BG-008 Deferred from current software handoff baseline Keep step 0 CGM-only via SRS-BG-012 Step-0 BG rescue is not part of the current accepted software baseline. Current implementation explicitly keeps it disabled. Re-open only if future approved baseline intentionally enables BG rescue at step 0.
SRS-MEAL-004 Accepted for current software handoff baseline Late meal submit executes on current due step This is implemented behavior, covered by current runtime/verification paths, and should be represented as accepted current software behavior in the handoff package. Downstream clinical/review team may still challenge or change it before formal release approval.
SRS-CLIN-002 Accepted as investigational control for current software handoff baseline Current baseline uses configured clinician passcode gate value 020508 The passcode gate is the current investigational software control. It is acceptable for the software handoff package if explicitly marked as an investigational control with required transition away from passcode-only gating. Replace with authenticated role-based access before production release baseline.
SRS-SEC-003..009 Deferred from current software handoff package Do not claim closure for auth/provider/authorization/session-continuity package in this week's handoff These rows still mix implemented development behavior, unresolved provider policy, authorization model decisions, and broader cloud/compliance scope. Re-open when auth/security/cloud scope is explicitly pulled into the package with quality-team alignment.

4. Verification Dispositions Affected

Verification Rows Current Disposition Reason
TV-BG-007 Deferred with SRS-BG-008 Step-0 BG rescue is not part of the current accepted software baseline.
TV-MEAL-003 Accepted in current software handoff baseline Matches accepted SRS-MEAL-004 behavior.
TV-SEC-002..008 Deferred from current software handoff package Follow deferred cloud/auth security verification scope decisions for this handoff pass.

5. Notes for Downstream Review