FDA's Approach to International Harmonization of Biomaterials and Tissue-Engineered Products

The possibilities for global regulation of tissue-engineered products are discussed. While issues of national sovereignty are likely to present difficulties, the international medical device community shares fundamental goals, and the potential benefits to global harmonization are substantial. The Food and Drug Administration (FDA) is collaborating currently with international organizations on an approach to attain these goals, with excellent results. The devices approach to harmonization presented at the meetings of the Global Harmonization Task Force in June 1995 is described. FDA believes a stepwise approach to harmonization is an effective and efficient approach to making progress. To do this, all parties must agree on steps to achieve harmonization in each area. It is highly desirable that each country reach the same definitions of tissue and tissue-engineered products and jurisdictional assignments for regulatory review, avoiding overlaps, so that the industry can deal more economically with regulatory oversight. The controls that the FDA applies to tissue-engineered products are discussed as well as the need to determine which major consensus standards group can organize the development of global, not just European, standards for tissue-engineered products. The FDA pledges its support to work toward regulatory harmonization of these products.