Tissue Reference Group

Tissue Reference Group
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 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.

The TRG gives recommendations to the Centers and through the Centers to the Office of Combination Products, which then communicate 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 to the Tissue Reference Group, please contact Ana Kolin, Executive Secretary for the Tissue Reference Group., Division of Human Tissues, Office of Cellular, Tissue, and Gene Therapies at 301-827-6037 , or by FAX at 301-827-2844 or by email at ana.kolin@fda.hhs.gov. Submissions for TRG recommendation can be emailed or mailed to Ana Kolin, at the Office of Cellular, Tissue and Gene Therapies, Food and Drug Administration, 1401 Rockville Pike, HFM-775, Rockville, MD 20852-1448.


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TRG Annual Reports
FY 2009 Update

The Tissue Reference Group made recommendations concerning the application of 21 CFR Part 1271.1, 1271.15, and 1271.20 to 4 HCT/Ps.

. Allogeneic retinal pigment epithelium and neurosensory cell layer for the treatment of patients with retinal degenerative diseases is considered a biological product subject to investigational new drug applications (INDs) and biologic license applications (BLAs), and not a 361 HCT/P because the product is dependent upon the metabolic activity of living (allogeneic) cells for its primary function (systemic effect).
. Allogeneic orthopedic tissue for replacement of knee ligaments is not a 361 HCT/P because the product is processed with a solution that contains an anti-inflammatory drug. The anti-inflammatory drug in the processing solution is not a sterilizing, preserving, or storage agent as described in 1271.10(a)(3) (combination with another product).
. Product containing tendon tissue, cancellous bone, and a polyester suture for use in ligament reconstruction is regulated as a medical device, and not a 361 HCT/P. The Tissue Reference Group made the same recommendation in the past, as stated in the FY 2002 Update below.
. Addition of a manufacturing hold stage whose purpose is solely an improvement in the processing efficiency and flexibility, during manufacturing of various cardiovascular tissues previously determined to be 361 HCT/Ps does not change the regulatory status of these tissues.

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FY 2008 Update

. The Tissue Reference Group made recommendations concerning the application of 21 CFR Part 1271.1, 1271.15, and 1271.20 to 7 HCT/Ps.

. Allogeneic freeze-dried, irradiated human peritoneal membrane used as a soft tissue wound covering is considered a 361 HCT/P.

. Allogeneic placental-derived extracellular matrix and hematopoietic progenitor cells contained in the placental vasculature of the same donor used for repair, replacement and/or reconstruction of bone defects is considered a biological product, and not a 361 HCT/P because of the non-homologous use, combination with another article and a systemic effect.

. An HCT/P where an antimicrobial considered to be a sterilizing, preserving, or storage agent per 1271.10(a)(3) is added to a solution used in the processing of the HCT/P to improve the solution’s antimicrobial properties is considered a 361 HCT/P.

. Allogeneic demineralized cancellous bone advertised for filling of osteochondral defects is considered a medical device and not a 361 HCT/P because use for filling osteochondral defects in the cartilage constitutes a non-homologous use.

. Autologous adipose tissue enzyme digested and processed for urinary incontinence and treatment of impotence is considered a biological product and not a 361 HCT/P because this is a non-homologous use. The tissue is recovered during one surgical procedure, then processed, and therefore the HCT/P is not exempt from the regulations under 21 CFR Part 1271.15(b).

. Decellularized allogeneic fascia lata and pericardium used as wound coverings for dura mater defects are considered 361 HCT/Ps.This use is considered an homologous use.

. Allogeneic demineralized bone matrix combined with human collagen derived from the same donor is a medical device. Processing of the carrier alters the original relevant characteristics of the demineralized bone matrix and this constitutes more than minimal manipulation.

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http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/RegulationofTissues/ucm152857.htm