RAPS is committed to bringing you the highest quality learning content and we are excited to debut a new course, Regulation of IVDs in the US and Major Markets Outside the US, in the coming weeks.

All RAPS Online University learners presently enrolled in either Regulation of IVDs in the US or Regulation of IVDs for Key International Markets, either individually or as part of a certificate program, are eligible to be upgraded to the new course at no additional cost.

While the courses Regulation of IVDs in the US  and Regulation of IVDs for Key International Markets  are being retired, you will retain access to your current course for the rest of your enrollment period. Plus, you'll have complete access to the new course when it opens later this spring. 

If you are presently enrolled in an IVD course, please contact the RAPS Solution Center by calling 301-770-2920 extension 200 and a customer service representative will be able to confirm your current enrollment and grant you access to the new course free of charge. The RAPS Solution Center may also be reached by emailing support@raps.org


Coming Soon: Regulation of IVDs in the US and Major Markets Outside the US

Course Overview

In vitro diagnostic devices (IVDs) drive a significant portion of clinical decision making today. IVDs assist in the identification, diagnosis and monitoring disease or other conditions and aid in the determination of states of health. These products are also intended for use in the collection, preparation and examination of specimens taken from the human body, including, for example, blood, tissue, urine, saliva, cerebrospinal fluid, hair and sweat. They play an ever-expanding role in the selection of appropriate therapeutic interventions in healthcare delivery, especially with the advent of “personalized medicine.” In vitro diagnostic products are considered a subset of medical devices in the US and are regulated by the Food and Drug Administration (FDA). Outside the US, in vitro diagnostic products are regulated either as a subset of medical devices or through a separate regulation specific to in vitro diagnostic devices.
This course provides a basic overview of IVDs, including an historical background focused on regulatory requirements. It introduces key regulations and guidelines necessary for effective product development. In addition, this course describes IVDs, regulatory aspects related to IVDs’ performance evaluation and testing, submission requirements for marketing authorization for IVDs, and IVD postmarket considerations such as adverse event and malfunction reporting.

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 device regulations.
  • Learning Level: Basic
  • Total Length of Course: 5 Hours
  • RAC Credits: 5

Learning Objectives

Upon completion of this course, participants should be able to:
  • Understand the historical evolution of regulatory oversight of IVDs
  • Discuss the current state of IVD regulations
  • Identify and explain areas of IVD regulations related to:
    • product classification
    • IVD development, testing and premarket submission
    • postmarket regulatory requirements and responsibilities for IVD manufacturers
  • Discuss IVD technologies and emerging trends
  • Apply IVD-specific regulations and guidelines for successfully traversing premarket and postmarket regulatory hurdles

Course Structure

  • Common Regulatory Requirements for all countries
  • Part 1: Inside the US
    • Lesson 1: Overview of In Vitro Diagnostics
    • Lesson 2: The Regulatory Basics
    • Lesson 3: Premarket Submissions
    • Lesson 4: Postmarket Considerations
    • Lesson 5: Other Considerations
  • Part 2 - Outside the US - IVD
    • Lesson 6: Regulation of IVD Products OUS – Harmonization, Laws, and IVD Classification
    • Lesson 7:Marketing Authorization – OUS
    • Lesson 8: Labeling Requirements OUS
    • Lesson 9: Quality System requirements 
    • Lesson 10: Postmarket OUS