Online CourseOnline Course Medical Device Certificate ElectiveMedical Device Certificate Elective

Regulation of IVDs in the US and Major Markets Outside the US [5.0 RAC]

5.0 RAC Credits Member: $545.00 Nonmember: $745.00
Regulation of IVDs in the US and Major Markets Outside the US [5.0 RAC]
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 Points: 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

Lesson Titles
  • 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

Enrollment Period: 12 months
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