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IDE Submission Closure Checklist

Status: Active working checklist Owner: BionicLoop engineering Last updated: 2026-04-06 14:30 EDT

Use this checklist to prepare a handoff-ready final draft IDE package in a traceable order.

This checklist is for engineering/package-prep ownership. It is not the formal quality/review/release workflow. The target state is:

  • final-draft documents prepared for review and approval
  • complete metadata needed for controlled release handling
  • explicit scope/defer/disposition records ready for the quality/submission team

A. Final-Draft Document Control Prep

  • [x] A1. Define final-draft document versions and review/approval metadata fields for:
  • RiskAnalysis.md
  • SoftwareRequirementsSpecification.md
  • SoftwareDesignDescription.md
  • SoftwareVerificationAndValidationPlan.md
  • TraceabilityMatrix.md
  • CybersecurityPlan.md
  • DevelopmentSOP.md
  • [x] A2. Add revision history table to each controlled document.
  • [x] A3. Replace all Draft v0.1 status lines with final-draft / pending-review status and prepared metadata fields (reviewer, approver, decision date, effective date) for later completion by the release-owning team.

Evidence target: - Docs/Quality/Evidence/Formal/STR-DOC-001/<run-label>/

B. Requirement Finalization

  • [x] B1. Disposition SRS-BG-008 with explicit IDE decision.
  • [x] B2. Record engineering disposition for SRS-MEAL-004 and note that downstream clinical/review approval remains outside engineering ownership.
  • [x] B3. Disposition SRS-SEC-003 through SRS-SEC-009.
  • [x] B4. Disposition investigational SRS-CLIN-002 control statement with transition requirement.
  • [x] B5. Remove unresolved language (provisional, pending team review, temporary) from controlled requirement text, or mark as explicit deferred item with rationale.

Evidence target: - Updated SRS + disposition log + linked sign-off records.

C. Design and Verification Alignment

  • [x] C1. Sync SDD sections to final SRS wording for all disposed items.
  • [x] C2. Sync SVVP test inventory to final SRS scope and remove ambiguous provisional test language.
  • [x] C3. Create final-draft STP documents mapped to all in-scope TV-* IDs.
  • Current STP set now carries final-draft handoff metadata, explicit TV-* ownership mapping, and prepared review/approval placeholders. Remaining open work is evidence execution / promotion, not protocol structure.
  • [x] C4. Ensure each STP has:
  • objective
  • setup/environment
  • procedure
  • expected results
  • pass/fail criteria
  • trace IDs

Evidence target: - Docs/Quality/STP/ controlled docs + cross-links from SVVP.

D. Risk and Security Closure

  • [ ] D1. Finalize risk scoring model and acceptance criteria in RiskAnalysis.md.
  • [x] D2. Record residual-risk sign-off as a receiving quality/submission ownership item rather than an engineering-owned closure task.
  • [x] D3. Expand CybersecurityPlan.md from high-level narrative to a current-scope control/evidence matrix with explicit deferred auth/cloud boundary.
  • [x] D4. Map each in-scope or deferred SRS-SEC-* row to specific verification or deferred evidence treatment (TV-SEC-* + scope decision).
  • [x] D5. Create a cybersecurity handoff register covering inherited supplier controls, BionicLoop-owned local controls, provenance gaps, and missing artifacts for the current software package.
  • [x] D6. Add supporting cybersecurity review notes for embedded-package provenance and the current local file/permission surface.
  • [x] D7. Add a dependency-inventory snapshot for the current cybersecurity/software handoff package.
  • [x] D8. Add a focused logging/secret-redaction review note for the current auth/network/telemetry surfaces.
  • [x] D9. Add a supplier-artifact request list for remaining inherited DASH/G7/Dexcom-app evidence asks.
  • [x] D10. Add an engineering baseline-acceptability recommendation for the current local export/file-sharing/logging posture.
  • [x] D11. Add a curated security-relevant local-delta review for the embedded LoopKit, G7SensorKit, and OmniBLE packages.
  • [x] D12. Add an SBOM/advisory-monitoring ownership and freeze-time generation process note for the software handoff package.
  • [x] D13. Add a freeze-execution checklist for in-scope TV-SEC-001 evidence promotion.

Evidence target: - Updated RA and cybersecurity control matrix + formal evidence links.

E. Formal Evidence Packaging

  • [ ] E1. Execute missing formal STR runs for rows currently marked Partial or Pending in RTM.
  • [ ] E2. Ensure all closure evidence is in formal lane only:
  • Docs/Quality/Evidence/Formal/
  • [ ] E3. Keep working evidence as development support only:
  • Docs/Quality/Evidence/Working/
  • [ ] E4. For each formal run, include:
  • command log
  • environment/tool versions
  • run timestamp
  • git SHA
  • pass/fail summary
  • generated artifacts checksum

Evidence target: - Formal STR bundles with reproducible metadata.

F. RTM Final Closure

  • [ ] F1. Update each in-scope RTM row status from In progress to Complete, or to approved deferred status with rationale.
  • [ ] F2. Replace Partial/Pending evidence fields with explicit formal STR references.
  • [ ] F3. Validate bidirectional links:
  • RA -> SRS -> SDD -> TV/STP -> STR -> RTM

Evidence target: - Finalized TraceabilityMatrix.md and independent link-check log.

G. Review / Handoff Package Assembly

  • [x] G1. Produce IDE final-draft document index with exact included versions and dates.
  • [x] G2. Produce unresolved items/deviation register (if any) with recommended approvers/owners and placeholder approval fields for the receiving team.
  • [x] G3. Produce current handoff summary using the readiness report + disposition log while formal freeze memo remains a receiving-team activity.
  • [x] G4. Create a dedicated concise review packet folder for the IDE software package and wire the quality indexes to use it as the default review entry point.
  • [x] G5. Produce a one-page handoff memo and a reviewer-facing RTM audit summary for the receiving team.
  • [x] G6. Produce the formal evidence execution plan for the current packet by protocol owner and freeze phase.
  • [x] G7. Prepare a receiving-team freeze disposition memo plus formal STR shell/template paths for the current freeze set (STR-ALG-001, STR-AUTO-001, STR-SEC-001).

Evidence target: - Docs/Quality/IDE_Submission_Readiness_Report.md updated to Final draft prepared for handoff state. - Final-draft package index and handoff memo.