ABSTRACT
A critical step in translating tissue engineering research into product applications for the clinic and marketplace is understanding the strategies developed by government agencies for providing appropriate regulatory oversight. Since the eventual goal is the establishment of a global industry with the ability of companies to market products across national boundaries, a harmonized international regulatory approach would be ideal. However, while groups actively work toward that end, and, recognizing that market acceptance can be influenced by local cultural, ethical, and legal concerns, it is essential to recognize and appreciate the approaches of the regulatory agencies of those countries where engineered tissue research is already moving into product development and clinical application. While the science in the field is now worldwide in scope [1], we will limit our discussion to the regulatory approaches of the United States, with attention to emerging trends in Europe and Japan.
