Diagnostic Development, Approval, and Reimbursement

  • Course Price: $150 USD
  • Course Run Time: 41 minutes
  • Course Level: Level 1 - Foundational
  • Completion Period: 2 week

Diagnostic Development, Approval, and Reimbursement begins by examining the big picture; the roles of U.S. government agencies and their regulatory authority over in vitro diagnostics (IVD) and laboratory-developed tests (LDT). The second section describes the regulatory requirements for Class I, II, and III diagnostic approval pathways. A review of the internationally recognized quality system regulations (QSR), focused on the design and manufacturing QSRs, closes out this section. Diagnostic Developemnt, Approval, and Reimbursement ends by explaining Medicare, Medicaid, hospital, and private payer reimbursement in terms of inpatient DRG codes and outpatient CPT codes. 

Suggested Prerequisites

Diagnostics’ Role in Medicine Today

  1. Compare and contrast the diagnostic regulatory oversight by the FDA and the CMS.
  2. Explain the United States regulatory process for in vitro diagnostics and laboratory-developed tests.
  3. Recognize the regulatory differences between Class I, II, and III diagnostics.
  4. Explain the purpose of quality system regulations (QSR) highlighting the design and manufacturing QSRs.
  5. Discuss the challenges in receiving diagnostic reimbursement in the United States.
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
Diagnostics: Regulation of New Clinical Tests
Summarizes the regulatory pathways for different categories of diagnostics and explains the differences in oversight from the Center of Medicare and M...More
Approval Process for Laboratory Developed Tests (LDT)
Compares the regulatory differences between in vitro diagnostics and laboratory developed tests.
Diagnostic Regulatory Pathways
Describes the regulatory burden of Class I, II, and III diagnostics and how to assess a diagnostic's class based on its risk profile. The FDA's 501(k)...More
Quality Control of Diagnostics
Highlights the application of quality system regulations for diagnostics.
European Union Approval Pathways for Diagnostics
Provides a synopsis of the EU's diagnostic approval process.
Reimbursement for Diagnostics
Describes the methodology for economic evaluation and reimbursement of novel diagnostics. Lastly, the US standard reimbursement codes for diagnostics are reviewed.
Final Quiz
LinkedIn Certificate Demo
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
You have two weeks from time of purchase to complete any of the online courses. For example, if you purchase the course at 9 am on Saturday, the course will close at 9 am 14 days later.

Our online classes are between 40 minutes and 85 minutes in length. We suggest allowing 20 minutes to take the end of the course quiz and 10 minutes to complete the class evaluation. 

Yes, each course has an accompanying pdf that contains all of the presented course information. 

There are no refunds once you have purchased an online course. 

The online classes are fully animated with a professional voice-over. Each course begin with an overview of what you will learn, the course itself, and then ends with a course quiz to assess your understanding.

You can repeat the class as often as you like within your two week run time.

You have two chances to pass the quiz. A passing score is 70% or higher. 

Each course is to be taken by one individual. If you would like to take our online courses as a group, please contact Stacey Hawkins at This email address is being protected from spambots. You need JavaScript enabled to view it. for pricing.

There are three requirements to receive your course certificate.

  1. You must view the entire course.
  2. You must pass the course quiz with a 70%.
  3. You must complete the course evaluation.

You can download and print your certificate from your dashboard only when all three of these items are completed. 

Before moving on to the next section of our on-demand, online courses, all slides within a section must be viewed.

There is an easy way for you to see which slides you have completed and not completed in the course. Look at the menu on the left side of the course- the slides that have been seen are darkened and the slides that have not been seen are light. 


BIO member discounts are available for on-demand, online classes. To access the BIO member discount, use your company email address during the checkout process. The checkout system will automatically recognize your organization and apply the 20% discount to your purchase if your company is a member of BIO. If you use a private email address we are unable to provide you the BIO membership discount.

If your on-demand course expires, but you have not completed it, you can extend it for an additional 2 weeks for $25.

  • Log into your dashboard
  • Go to the on-demand course you want to extend
  • The "Course Extension" button brings you to the payment gateway
  • Please note: It will appear you are being asked to pay the full amount of $150, but a discount will be automatically given once you fill in all of your payment information. 

You have 90 days, from the day your course expires, to take advantage of this nominal extension fee. Once the 90 days are past, you will need to pay the full price to view the course again. 

  1. Once your online course starts click on “Resources” in the upper right-hand corner
  2. In the drop down menu find the link “Course Slides”
  3. Download and/or print 
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent