Diagnostic Development Primer | CPE

- Level: Beginner
- CPE: 1.5 Credits
- Time: 41 Minutes
Diagnostic Development Primer offers a comprehensive guide to IVD and LDT approval pathways, covering FDA regulations, Class I-III requirements, and QSR impact. Guidance on securing diagnostic reimbursement from Medicare, Medicaid, hospitals, and private payers to ensure commercialization success.
- Understand the diagnostic development process to make smarter investment, partnership, and commercialization decisions in a rapidly growing market
- Gain insight into regulatory requirements and market dynamics that shape diagnostic success
- Explore the critical role of companion diagnostics in personalized medicine and their impact on biopharma partnerships
- Best Value: Unlimited Learning
- Purchase Single Course
Choose your subscription and start exploring a rich library of expert led, on-demand biotech training.
- Up to 12-month unlimited access
- Content designed for all skill levels: Beginner to Advanced
- CPE credits included with every course
- Learn at your own pace
- Choose the subscription plan that fits your goals
Get full access to this course with a one time purchase.
- 1-month access to all course material
- CPE credits included
- No subscription required
- Self-paced and on-demand
- Ideal for focused, one-off learning
- Overview
- Agenda
- Features
- Justify This Training
- FAQ
Watch Trailer
Agenda
-
Development and Regulation
Summarizes the regulatory pathways for various types of diagnostics, comparing FDA and CMS oversight, and highlighting key differences between in vitro diagnostics and laboratory-developed tests.
-
Diagnostic FDA Classification and Approval Pathways
Explains diagnostic regulations by classifying risk for Class I-III devices and outlining FDA pathways such as 510(k), de novo 510(k), and PMA.
-
Reimbursement
Describes the methodology for economic evaluation and reimbursement of novel diagnostics.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
Justify This Training
View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.
FAQ
Our Executive
Certifications
Cannot make our live class? Consider one of our Executive Certifications.

Biotechnology Executive Certification
- Level:Beginner
- CPE:14.50 Credits
- Time:12 Hours
- Total:12 Courses

Drug Development Executive Certification
- Level:Beginner
- CPE:13.50 Credits
- Time:10.5 Hours
- Total:12 Courses

Drug Manufacturing Executive Certification
- Level:Beginner
- CPE:14.50 Credits
- Time:10 Hours
- Total:11 Courses

Medical Device Executive Certification
- Level:Beginner
- CPE:12.00 Credits
- Time:8 Hours
- Total:9 Courses