Extract to table

reference blood glucose measurement) must fall within Zones A and B on the Clarke Error Grid

regulatory submissions and obligations, the contractual privity must reside with SBI

Part 812 — Investigational Device Exemptions • Applicable FDA guidance documents, including guidance pertaining to integrated continuous glucose monitoring (iCGM) systems, clinical study design for CGM devices, and the use of real-world evidence in device submissions The MSA must impose upon Veltrano CRO a binding obligation to comply with all such regulations and guidance, and must allocate responsibility between Veltrano CRO and SBI for the various regulatory compliance activities associated with the Study

Given that the LUMINA-US Study is the pivotal clinical investigation supporting the 510(k), the data generated must be in a form that is directly usable by Pinnacle Regulatory and SBI in assembling the submission package

Given the aggressive timeline and the importance of the Study data to the 510(k) submission, SBI must have regular and comprehensive visibility into study progress

We recommend the inclusion of a quarterly budget reconciliation process under which Veltrano CRO is required to provide SBI with detailed cost reports showing actual expenditures compared to budgeted amounts, broken down by cost category