Tissue Reference Group

The TRG was created as specified in the "Proposed Approach to the Regulation of Cellular and Tissue-based Products" published by FDA in February of 1997. The TRG is composed of three representatives from the Center for Biologics Evaluation and Research (CBER) and three from the Center for Devices and Radiological Health (CDRH), including the product jurisdiction officer at each Center. An executive secretary carries out the functions described below. A liaison from the Office of Combination Products and the Office of the Chief Counsel attends meetings. Other FDA staff are asked to attend meetings as needed, to discuss issues related to HCT/Ps in their area of expertise.

CBER and CDRH intend to provide a single reference point for product-specific questions received by the Centers or the Office of Combination Products from manufacturers and sponsors or their designated representatives regarding existing or investigational products containing or consisting of HCT/Ps. The TRG considers theses questions and prepares recommendations regarding jurisdiction, policy, and regulations related to novel HCT/Ps to promote consistency.

Updated: November 4, 2005