The Tissue Reference Group (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 purpose of the TRG is to provide a single reference point for product specific questions received by FDA (either through the Centers, or from the Office of Combination Products) concerning jurisdiction and applicable regulation of human cells, tissues and cellular and tissue-based products (HCT/Ps).
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 handles administrative functions for the TRG. A liaison from the Office of Combination Products and from the Office of the Chief Counsel attends meetings. Other FDA staff attend meetings as needed to discuss issues related to HCT/Ps in their area of expertise.
The TRG provides recommendations to the Centers and through the Centers to the Office of Combination Products, which then communicates with the sponsor. These recommendations are based on the information known at the time and are subject to change.
If you have questions or wish to send a request for recommendation to the Tissue Reference Group, please contact the Executive Secretary for the Tissue Reference Group, Division of Human Tissues, Office of Tissues and Advanced Therapies (OTAT) by FAX at 301-595-1303 or by email at TissueReferenceGroup@fda.hhs.gov. Submissions to the TRG can be emailed or mailed to the Tissue Reference Group at the Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Food and Drug Administration, 10903 New Hampshire Avenue, Building 71, Room G112, Silver Spring, MD 20993-0002.
To facilitate review of your inquiry by the TRG, you may want to include the following:
- your name and contact information, and if applicable, the name and contact information of the party you represent;
- manufacturer of the product;
- any proprietary names and common names associated with the product;
- source of the product including how the HCT/P is recovered;
- a clear, step-by-step description of how the product is processed, packaged (including the range of product sizes, when applicable), and stored;
- the way the product is to be used and product labeling, including package inserts and any Instructions for Use documents; and
- how the product meets all the criteria in 21 CFR 1271.10(a).
NOTE: The TRG may request additional or clarifying information if it is needed to make a recommendation. Inconsistencies in the information submitted may cause delays.