Diagnostic Development Primer

Diagnostic Development Primer is a comprehensive guide to navigating the complex world of approval pathways. This class begins by examining the vital roles that various United States government agencies play in regulating In Vitro Diagnostics (IVD) and Laboratory-Developed Tests (LDTs). It provides a detailed description of the regulatory requirements for Class I, II, and III diagnostic approval pathways. A review of the internationally recognized Quality System Regulations (QSR) and how they impact the design and manufacturing of diagnostic products closes out section two. This primer wraps up by explaining the reimbursement process for Medicare, Medicaid, hospitals, and private payers, breaking down complex inpatient DRG codes and outpatient CPT codes. Enroll now in the Diagnostic Approval Primer and become well-versed in the approval process of molecular diagnostics. Let’s start your journey today!

Section 1: Development and Regulation

Summarizes the regulatory pathways for different categories of diagnostics and explains the differences in oversight from the Center of Medicare and Medical Services with the FDA. Moreso, compares the regulatory differences between in vitro diagnostics and laboratory developed tests.

Section 2: Diagnostic FDA Classification and Approval Pathways

Learn to navigate diagnostic regulations, classify risk profiles for Class I, II, and III diagnostics, and understand FDA pathways like 501(k), de novo 510(k), and premarket approval. Explore quality system regulations and gain insights into European Union approval pathways for diagnostics.

Section 3: Reimbursement

Describes the methodology for economic evaluation and reimbursement of novel diagnostics. Lastly, the US standard reimbursement codes for diagnostics are reviewed.

Five Takeaways


  1. Compare the diagnostic regulatory oversight by the FDA and the CMS.
  2. Understanding of Contrast the United States regulatory process for in vitro diagnostics and laboratory-developed tests.
  3. Recognize the regulatory differences between the Class I, II, and III diagnostics.
  4. Explain the purpose of quality system regulations (QSR), highlighting the design and
    manufacturing of QSRs.
  5. Discuss the challenges in receiving diagnostic reimbursement in the United States.

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