Medical Device Advertising and Promotion - FDA's Framework (1.5 hours)

This course is designed to provide an overview of US regulatory requirements for advertising and promotion of medical devices, with a focus on FDA as well as the corresponding standards, policies, procedures, and guidelines that apply to advertising and promotional activities. Upon completion of this course, learners will understand how advertising and promotion are defined, the required elements of advertising and promotional materials including on social media platforms, roles and responsibilities, and the regulatory risks associated with advertising and promotional activities.

Key learning objectives:

• Identify what type of material and activities are considered “Advertising and Promotion”.
• Identify applicable regulatory requirements.
• Identify key factors to be considered when creating, distributing, and reviewing Advertising and Promotion material.
• Recognize that Advertising and Promotion requirements apply to work performed by all functions across the full product life cycle.
• Explain the specific responsibilities of management to meet those requirements.
• Identify situations and statements making medical claims that must be substantiated by an FDA cleared or approved marketing application.
• Identify the risks of using social media platforms to collect user/patient/customer feedback and how to mitigate those risks.
• Recognize the impact and potential outcomes of violating Advertising and Promotion requirements.
• Recognize the impact and potential outcomes of violating Advertising and Promotion requirements.