BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
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!
Takeaways
- Compare the diagnostic regulatory oversight by the FDA and the CMS.
- Contrast the United States regulatory process for in vitro diagnostics and laboratory-developed tests.
- Recognize the regulatory differences between the Class I, II, and III diagnostics.
- Explain the purpose of quality system regulations (QSR), highlighting the design and manufacturing of QSRs.
- Discuss the challenges in receiving diagnostic reimbursement in the United States.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
Discover the expanding molecular diagnostics field, saving lives by pinpointing disease causes and guiding personalized treatments."
Explore diagnostic accuracy measurements: false negatives, false positives, variability, sensitivity, specificity. Essential for regulatory approval."
Explore US medical device regulation: classification, approval pathways, FDA guidelines, quality regulations, risk management.
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Discover the expanding molecular diagnostics field, saving lives by pinpointing disease causes and guiding personalized treatments."