Food and Drug Administration commentary on “A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves”

Abstract

In January 2010, the US Food and Drug Administration (FDA) and AdvaMed organized a workshop for developing a pathway to market for pediatric heart valves. This meeting included representatives from the device industry, medical community, academia, and the FDA. It resulted in a detailed pathway for gaining market approval for pediatric-sized heart valves to address the unmet need for these heart valves. The article titled, ‘‘A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves,’’ by Yoganathan and colleagues, presents this pathway to evaluate the safety and effectiveness of specific types of pediatric heart valves. In particular, this pathway is presented for smaller sizes of surgically implanted heart valves that already have premarket approval in the United States, comprising the samematerials andmanufactured by the same processes, and could be reviewed through a premarket approval supplement application. The underlying theme of this pathway is leveraging our existing knowledge about adult-sized heart valves and encouraging a more global approach for future device development. A key component of this pathway is the total product life cycle approach, with which we can leverage the many facets of the review process to bring these devices to market. With this approach, accelerated wear testing, hydrodynamic testing, flow visualization analysis, and kinematic assessment would be conducted for the new valve sizes. If the new valve size represents worst-case loading conditions, new fatigue testing would also be conducted. Because the new sized valve has the same design and is made of the same materials, however, new animal testing and testing for biocompatibility and sterilization would not need to be conducted. Because there is also presumably extensive clinical experience with the valve model, we can