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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Diagnostic Development & Approval Course Trailer


  • 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.
Course Price:
$150 USD
BIO Member Price:
$120 USD
Course Length:
50 minutes
Course Level:
Completion Period:
2 weeks
Course Format:

Certificate Requirements

  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation
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