This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of tissue engineered medical products (TEMPs) intended for use in the surgical repair and/or replacement of heart valves. This guide is intended for use related to the in vitro assessment of TEMP heart valves.
heart valves; heart valve substitutes; tissue engineered medical products; TEMPS
There is currently no standard guide to assist heart valve TEMP manufacturers with in vitro assessment.
The title and scope are in draft form and are under development within this