Medical device manufacturers risk violating the Federal Food, Drug, and Cosmetic Act (FDCA) if their advertising in support of a product are not consistent with product’s FDA cleared or approved use. The regulation of promotional materials and activities also fall within the jurisdiction of the Federal Trade Commission. Industry takes its responsibilities seriously to ensure compliance, foster responsible and informative DTC communications, and encourage discussion with health care professionals to learn about healthcare treatment options.
Postmarket
Through review of a Premarket Approval Application (PMA), FDA evaluates the safety and effectiveness of Class III medical devices. To help assure the continued safety and effectiveness of an approved device, in some cases FDA may require a post-approval study, also referred to as condition of approval study. A post-approval study may be a clinical or non-clinical study required at the time of approval and is intended to gather specific information to address questions about the postmarket performance of or experience with an approved medical device.