Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Scott A. Brubaker
Director
Division of Human Tissues (DHT)
Office of Cellular Therapy and Human Tissue (OCTHT)
Office of Therapeutic Products (OTP)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Scott A. Brubaker is the Director of the Division of Human Tissues, Office of Cellular Therapy and Human Tissue, in the Office of Therapeutic Products, at the Center for Biologics Evaluation and Research, FDA. Prior to selection in October 2016 as the Director of the Division of Human Tissues, Mr. Brubaker served 12 years as Sr. Vice President of Policy at the American Association of Tissue Banks where his duties included the development and management of Association policies, professional standards and guidance documents, and oversight of the Accreditation Program. Prior to that, Scott acquired 18 years of practical experience involving organ donation and tissue banking while holding various management positions at an organ procurement organization/tissue bank in Virginia. Scott has authored or co-authored more than 40 publications and is co- editor of 3 essential guides (books) for tissues and cells that cover donation, processing, and clinical use.
Abstract
This presentation provides an overview of FDA regulations for screening and testing donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCTPs). Reflecting on the history of disease transmission via medical products of human origin, it emphasizes the critical goal of protecting public health by preventing the introduction and spread of communicable diseases. A fundamental requirement is the HCTP donor eligibility determination, which applies to all HCTPs regardless of how they are regulated. This determination relies upon comprehensive donor screening for risk factors and clinical evidence of Relevant Communicable Disease Agents and Diseases (RCDADs) and associated risks, involving review of medical history and physical assessment. It also requires donor testing for RCDADs and other specified agents, using qualified specimens collected at appropriate times and analyzed by certified laboratories. Examples of RCDADs include HIV, HBV, HCV, TSEs, and Syphilis. Establishments must adhere to Current Good Tissue Practice (CGTP) requirements. If regulatory requirements cannot be fully met, establishments have the option to submit a request for an exemption or alternative to the FDA, which requires supporting information and prior approval. Understanding and adhering to these regulations is essential for ensuring the safety profile of HCTPs and protecting public health.