Medical Devices: Advertising and Promotion in the US
Advertising and promotion are important tools used by medical device companies to educate consumers and healthcare professionals and to increase awareness of their products.
In the US, laws and regulations ensure that promotions contain truthful, not misleading, information about medical devices. Regulatory affairs professionals play an important role in helping a firm to maintain compliance with these laws and regulations while still meeting marketing and promotional objectives.
This course provides information regarding the primary US agencies regulating medical devices and covers their enforcement tools as well as company strategies for avoiding enforcement actions. Included are guidelines for regulatory reviews 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
- 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 Hours
- RAC Points: 3
- Medical Device Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:- Locate and explain the regulations for advertising and promotion of medical devices in the US market, and describe how to apply them appropriately
- Prepare for an effective regulatory review of medical device promotional materials
- Identify pitfalls in medical device promotions, such as off-label promotions
- Identify claims and determine appropriate substantiation for use in promotion
- Describe current trends in promotion and enforcement
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
This course is also included in:
