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 & Approval
Diagnostic Development and Approval describes the regulatory pathways for different categories of diagnostics, emphasizing the differences between in vitro diagnostics and laboratory-developed tests. Quality system regulations are extensively reviewed. The course ends with a discussion on the economic evaluation of novel diagnostics. Diagnostic Development and Approval helps anyone in the diagnostics industry expand their diagnostics development acumen.
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Takeaways
- Discuss the differences in diagnostic oversight by the FDA and the CMS.
- Explain the US regulatory process for in vitro diagnostics with laboratory developed tests.
- Recognize FDA’s Class I, Class II, and Class III diagnostics.
- Summarize the EU diagnostics approval process.
- Discuss the challenges in receiving diagnostic reimbursement in the US.
Certificate Requirements
- View the entire course
- Pass course exam with a 70 percent
- Complete the course evaluation
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