Enhanced Documentation Level and FDA Content Crosswalk¶
| Field | Value |
|---|---|
| Device software | BionicLoop investigational automated insulin-delivery controller |
| Documentation level | Enhanced |
| Basis | Software failure or latent defect could contribute to incorrect or delayed insulin delivery and serious injury |
| Baseline | ide-software-freeze-2026-08-21 / 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e |
| Reference | FDA, Content of Premarket Submissions for Device Software Functions, June 2023 |
| Status | Enhanced Documentation Level determination approved within the final software package |
| Date | 2026-09-08 |
Determination¶
BionicLoop uses glucose and pump feedback to calculate and command insulin delivery. A software defect could contribute to excess insulin, insufficient insulin, or an interruption of automated delivery. Because those outcomes could cause serious injury, the software package uses the FDA Enhanced Documentation Level. This determination does not depend on the size or phase of the proposed investigation.
Content Crosswalk¶
| Enhanced documentation content | Controlled artifact | Package location/status |
|---|---|---|
| Documentation-level rationale | This document; IDE Software Submission Core | Core and Appendix A00 |
| Software description and system context | IDE Software Submission Core; IDE Software Device Description for the Frozen Baseline | Core narrative and controlled supporting description |
| Software requirements | Software Requirements Specification, version 1.82 | Appendix A01 |
| Architecture and detailed design | Software Design Description, version 1.84 | Appendix A02 |
| Risk management | Controlled Software Risk Analysis, version 1.53; Known Anomalies and Residuals | Appendix A03 and Core |
| Software verification and validation | Software Verification and Validation Plan, version 1.91; Formal Evidence Index; Freeze Execution Report | Appendices A04, A07, and A11 |
| Requirements/design/risk/test traceability | Requirements Traceability Matrix, version 1.86 | Appendix A05 |
| Cybersecurity | Cybersecurity Plan; Cybersecurity Closure Matrix; SBOM and Advisory Review | Appendices A06, A08B, and A08C |
| Software version and configuration identification | IDE Software Version and Configuration Identification; Build 843 freeze delta and designation form | Appendices A10 and A10C |
| Software history and unresolved anomalies | Revision histories; Known Anomalies and Residuals | Controlled source documents and Core |
| Labeling and operating instructions | IFU-BL-001 | Appendix A09, supplied as a separate controlled PDF |
| Post-approval change control | Post-Approval Software Change-Control and Regulatory-Classification Procedure | Appendix A12 |
Approval and Submission Boundary¶
The documentation-level determination and final software package are approved. The IDE Submission Decision Register records the closure basis and the accepted RA-023 predeployment condition. Final FDA assembly, IRB records, and other nonsoftware submission elements remain under study-team control.