Transition from LDT to FDA Approved- Step-By-Step Guide

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The article outlines the key steps for transitioning  a Laboratory Developed Test (LDT) to an FDA-regulated In Vitro Diagnostic  (IVD), focusing on regulatory submissions, quality management systems, and  clinical validation. It highlights the importance of ISO 13485 compliance and  risk management throughout the process. The guide provides a roadmap for  successfully commercializing diagnostic products in the IVD market.