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.


  • 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


  • How long do I have to complete an on-demand course?  You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
  • What happens if I don’t complete the course in one year?  There are no time extensions. If you want to complete the course, you must purchase it again.
  • How long are the on-demand classes?  Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes.  The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
  • Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
  • What is the format of the on-demand classes?  The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
  • Can I repeat the course?  You can repeat the course as often as you like within your one-year access.
  • How many times can I take the course quiz?  You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
  • May I share a course I purchased with others?  Each course is to be taken by one individual. If you want to learn as a group, please contact us at training@biotechprimer.com for group pricing.

Ready to get started?

Get in touch or enroll now

Powered By MemberPress WooCommerce Plus Integration