In this course, we explore the expansive industry that produces laboratory tests, reagents and protocols required to detect and treat illnesses referred to as “Laboratory Developed Tests (LDT). We discuss the history of LDT and the rationale behind the FDA proposal to reduce or eliminate the potential errors associated with LDT similar to requirements for manufacturers of medical device. We will also understand the rationale behind the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 resurrected from Covid 19 testing concerns. For proactive compliance, we will learn the steps to develop a robust quality management system that will adhere to requirements for development of Laboratory developed tests. The learner will understand accreditation, regulatory and compliance requirements surrounding LDT and learn the process of a cross walk between the existing standards within the quality management system in comparison to regulatory requirements. We identify missing policies, procedures and processes to develop a Quality Management System Framework that will adhere to CLIA, comply with FDA pertinent regulations and expedite test development.