Medical Devices: Advertising and Promotion in the US [3.0 RAC]

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.