Regulatory Approved Point-of-Care Diagnostics (FDA & Health Canada): A Comprehensive Framework for Analytical Validity, Clinical Validity, and Clinical Utility in Medical Devices.

Abstract

Point-of-care (POC) diagnostic devices deliver rapid, near-patient results that drive timely clinical decisions across diverse settings (from emergency departments to home care). Their decentralized deployment mandates a rigorous, multi-phase validation strategy to ensure analytical accuracy, clinical reliability, and real-world utility before both regulatory clearance and reimbursement. We propose an expanded, integrated framework comprising 4 pillars:Analytical validity: Quantification of sens