Medical device promotion is an essential component of successful product commercialization, and the FDA has broad authority over the labeling of all devices as well as the advertising of “restricted devices”. While various similarities between the FDA’s regulation of medical device and drug promotion do exist, there are numerous important distinctions and, in recent years, greater enforcement of device promotion than drug promotion. Until FDA releases additional guidance in the labeling and promotion area, manufacturers must ensure their sales and marketing teams and promotional review committees adhere to FDA’s expectations to minimize their risk exposure.
- Current promotion recommendations and regulations and FDA guidance development priorities
- Analysis and takeaways from recent enforcement activities
- Case studies: Industry polling on compliance vs. non-compliance
Julie K. Tibbets
Alston & Bird LLP
Brooke Akins | Manager, Market Intelligence | 312.224.1693 email@example.com