TEMPS or tissue engineering is a rapidly growing field of research. The goal for developers is to cultivate a targeted tissue or organ rather than replace it with a prosthetic device. In most cases, the cellular materials used will be human derived, and perhaps from the patient. Typically the cells are seeded onto a substrate and allowed to proliferate until an adequate amount of tissue or cells are available for transplant to the patient. At best, the final "device" is generally considered a combination product subject to multi-agency review and approval.
In vitro and in vivo models to evaluate the safety or compatibility of the cellular material are very specialized and specific to the cells being incubated. The evaluations of cellular materials fall outside the preview of ISO 10993, the primary international guidance for the evaluation of medical devices. The substrate or matrix materials used to "seed" the cellular materials are subjected to routine device evaluations. Typically these products are considered as implants that degrade or absorb, leaving only the cellular component behind. In other cases, the substrate or protective polymer is considered a permanent implant that allows the cells to function without rejection.
Standards and Regulation
The polymer matrix or substrate is subject to ISO 10993 evaluations. Various guidance documents have been approved by ASTM and other standards organizations for development, handling and control of the tissue or cellular component of the TEMPS.
Note: Processed cells or tissues such as a collagen, demineralized bone, porcine heart valves and so forth are considered medical devices and not TEMPS, and are subject to the requirements of ISO 10993.
