Diagnostic Development & Approval

  • Course Price: $150
  • BIO Member Price: $120
  • Course Run Time: 50 minutes
  • Course Level: Level 1 - Foundational
  • Completion Period: 2 week

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.

Suggested Prerequisites

Diagnostics’ Role in Medicine Today

Takeaways
  1. Discuss the differences in diagnostic oversight by the FDA and the CMS.
  2. Explain the US regulatory process for in vitro diagnostics with laboratory developed tests.
  3. Recognize FDA’s Class I, Class II, and Class III diagnostics.
  4. Summarize the EU diagnostics approval process.
  5. 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
Trailer
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
Course Evaluation
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation
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.

You can pay an additional fee for an extension.

Our online courses 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 for the course evaluation. 

Yes, each course has an accompanying pdf that contains all of the presented course information. You will be able to download the pdf once you have registered for the course. 

There are no refunds if you decide to not take the course once you have registered. 

The online courses 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 course 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.

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. 

 

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