Significance and UseThis guide describes the general product development criteria and analyses applicable to processing of cells, tissues, and organs used for the production of TEMPs. For the purposes of this guide, cells, tissues, and organs may be derived from any organism at any developmental stage and in any state of health. For example, this guide applies to stem, progenitor, somatic, and germline cells, as well as cells from specific tissue and organ types. This guide also applies to cells, tissues, and organs from healthy, diseased, or injured embryos to adults. Cells, tissues, and organs may be combined with a scaffold and may contain locally or systemically acting biomolecules or a drug (medicinal) product. This type of TEMP would be a “combination product.”Scope1.1 This guide describes the processing, characterization, production, and quality assurance of cells, tissues, and organs used for Tissue Engineered Medical Products (TEMPs). It concerns aspects of processing activities for cells, tissues, and organs to be further processed. These aspects include: (1) cell, tissue, and organ processing (that is, facility, reagents, and procedures for receipt, inspection, and storage; tissue culture components, biological risk factors, and processing area), (2) donors (human and nonhuman) and screening, and (3) cell, tissue, and organ characterization and processing. 1.2 This guide does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration (FDA) under 21 CFR Parts 16 and 1270 (1) and 21 CFR Parts 207, 807, and 1271 (2). 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.
