Watch our free webinar: Laboratory Developed Tests: Issues and Anticipated Regulations

What you need to know about the shift from manufacturer-based oversight to the new risk-based approach for LDTs.

Since 2014, the FDA has been adopting a risk-based approach to regulatory oversight for LDTs which replaced the older system which focused on the type of manufacturer or laboratory involved.

In this Webinar, instructor Larry Stevens, RAC, will walk you through this new risk-based approach in detail, giving you all the information you need to anticipate the new regulations.

You’ll learn:

  • How the new regulatory approach differs from the old one
  • An overview of relevant draft guidances issued by the FDA
  • Answers to common questions regarding LDTs and their regulatory requirements

45-minute presentation with 15 minutes of Q&A.