Medical Devices: Advertising and Promotion in the US

This course provides information on the US agencies that regulate medical devices, their enforcement tools, as well as strategies to avoid enforcement actions. Included are guidelines on the information needed for a regulatory review of medical device advertising, methods used to identify claims in promotional materials and how to evaluate evidence to substantiate various types of claims. A review of current promotional issues and enforcement trends is also included.

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

At A Glance

  • Target Audience: This course is designed for regulatory personnel and others interested in the regulations that apply to the advertising and promotion of medical devices in the US who have minimal to mid-level regulatory experience.
  • 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
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Learning Objectives

Upon completion of this course, participants will be able to:

  • Properly identify the IVD category or risk classifications applicable in each of the subject markets
  • Describe and understand the regulatory requirements for obtaining market clearance
  • Identify an appropriate path for obtaining market clearance in Europe, Canada or Japan, and understand where to seek further guidance
  • Identify core requirements common to IVD regulation in most global markets

Lesson Titles

  • Lesson 1: Regulatory Framework for Product Promotion
  • Lesson 2: Regulatory Framework for Review of Product Communications
  • Lesson 3: Claims Substantiation
  • Lesson 4: Emerging Trends in Product Promotion

Learning Activity


Using product advertisements evaluated by the US Food and Drug Administration, hone your ability to identify problematic elements and/or answer questions about the appropriateness of the claims made.

Registration Options

This course is available for purchase as follows: