Chapter 65 - Regulatory Considerations

Abstract

This chapter provides background of the regulatory considerations related to the Food and Drug Administration (FDA) review and approval of tissue-engineered medical products. Tissue engineering, which applies life sciences and engineering principles to the maintenance, modification, improvement, restoration, or replacement of human tissue or organ function, has led to a broad range of products based on their common source materials—that is, human tissues or organs (for example, autologous or allogeneic tissues); animal tissues or organs (for example, transgenic animals or xenotransplants); and processed, selected, or expanded human or other mammalian cells (for example, stem/progenitor cells, genetic and somatic cellular therapies), with or without biomaterials and totally synthetic materials of biomimetic design. Representatives of these product classes are in different stages of development. To date, some have been approved for use by the FDA and many are under either preclinical investigation or regulatory evaluation. The review of products is conducted on a case-by-case basis and the product's safety and effectiveness are assessed with respect to its manufacture and clinical performance, as applicable, as well as the manufacturer's claim of intended use.