Beyond identifying a combination, I wanted to touch upon some of the challenges that surface when understanding the classification, and jurisdiction of these products. Common challenges include legal issues, marketing, premarket, post market, and cross labeling. Legal issues arise because there currently statutory or regulatory standards for combination products are not well defined. Additionally, marketing strategies are not the same in different markets (eg. biological products and device industries). Premarket and post market challenges are typically due to different data requirements, review timelines, factors such as promotion and advertising, and regulatory requirements in the different markets. Labeling challenges include labeling consistency, proprietary data reliance, coordination of changes, coordination of marketing review, and authorization.