Regulation of IVDs in the US

In vitro diagnostic (IVD) products drive a significant portion of clinical decision making today. IVDs assist in the identification, diagnosis and monitoring of disease. They play an ever-expanding role in the selection of appropriate therapeutic interventions in healthcare delivery with the advent of personalized medicine. These key products are a distinct class of medical devices regulated in the US by the Food and Drug Administration (FDA).

This course provides a basic overview of in vitro diagnostic medical devices with a focus on FDA’s regulatory requirements. It introduces key regulations and guidelines necessary for effective product development, explains what IVDs are and describes development and testing, getting a product to market, product review and FDA submission requirements.




  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Registration Options

At A Glance

  • Target Audience: This course is designed for new and experienced regulatory professionals interested in learning the basics of in vitro diagnostic medical devices regulations.
  • Learning Level: Basic
  • Total Length of Course: 3–6 Hours
  • RAC Credits: 3
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $360; List $495
  • Need more information?
    View the RAPS Online University FAQs.

Learning Objectives

Upon completion of the course, participants should be able to:

  • Discuss the current state of IVD regulations in the US and other regions
  • Identify and explain areas of IVD regulations related to:
    • product classification
    • IVD development, testing and premarket submission
    • postmarket regulatory maintenance and responsibilities for IVD manufacturers
  • Identify potential future challenges facing IVD manufacturers
  • Discuss IVD technologies and emerging trends
  • Apply IVD-specific regulations and guidelines for successfully traversing regulatory hurdles

Lesson Titles

  • Lesson 1: Overview of In Vitro Diagnostics
  • Lesson 2: The Regulatory Basics
  • Lesson 3: Premarket Submissions
  • Lesson 4: Post Clearance/Approval Considerations

Registration Options

This course is available for purchase as follows: