Abstract
As tissue engineering products are evolving, so too are the regulatory approaches to these products. Tissue engineering product development for the United States market is facilitated by an understanding of how the U.S. Food and Drug Administration (FDA) regulates tissue engineering products. New product innovations often require a coordinated effort by industry, academic investigators, and regulatory bodies to develop a degree of oversight that retains appropriate safeguards, incorporates public discussion, yet facilitates product development. A worldwide market has highlighted the importance of harmonized regulations and the world authorities are working together to standardize requirements. Xenotransplantation provides an example of an emerging technology that has significant public health ramifications which can best be addressed by public discussion, international collaboration, and a scientifically sound regulatory approach. The U.S. Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation has been developed to address these issues (61 FR 49920, September 23, 1996).
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