Overview of FDA Regulation of Human Cellular and Tissue-Based Products

摘要

Over the years the Food and Drug Administration (FDA) has regulated most cellular and tissue-based products on a case-by-case basis. Technological advancements have resulted in the development of new products and increasing numbers of transplantations. Many of these products are used in novel ways that warrant clinical evaluation, while some of the uses would be considered medical practice. As described later in this article, FDA's major concerns relating to oversight of some of these products pertain to protection of recipients from transmission of communicable disease, safety during processing and storage, efficacy, the need for reliable recordkeeping, and both product and recipient identification.