Chapter II.17 - Tissue Engineering: Product Applications and Regulatory Issues

Abstract

Publisher Summary The Food and Drug Administration (FDA) recognizes that an important segment of the products that it regulates arises from new technological achievements and innovations. One example is products developed through tissue engineering (TE) technology, i.e., tissue engineered medical products. Tissue engineering is the application of the principles of life sciences and engineering to develop biological substitutes for the restoration, maintenance, modification, improvement, or replacement of tissue or organ function. In the broadest sense, tissue engineered medical products span a spectrum of products including transplanted human tissues or organs (i.e., autologous or allogeneic tissue); animal tissues or organs (e.g., transgenic animals or xenotransplants); processed, selected, or expanded mammalian cells (e.g., somatic and genetic cellular therapies) in combination with or without biomaterials; and totally synthetic materials of biomimetic design. Both the range of products and the rapid evolution in product design have generated a certain degree of ambiguity in the definition of tissue engineered medical products. There is no precise and globally accepted definition for tissue-engineered products (TEPs).