Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. The Center for Biologics Evaluation and Research (CBER) regulates HCT/Ps under 21 CFR Parts 1270 and 1271. Examples of such tissues are bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes and semen. CBER does not regulate the transplantation of vascularized human organ transplants such as kidney, liver, heart, lung or pancreas. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs.
Parts 1270 and 1271 require tissue establishments to screen and test donors, to prepare and follow written procedures for the prevention of the spread of communicable disease, and to maintain records. FDA has published three final rules to broaden the scope of products subject to regulation and to include more comprehensive requirements to prevent the introduction, transmission and spread of communicable disease. One final rule requires firms to register and list their HCT/Ps with FDA. The second rule requires tissue establishments to evaluate donors, through screening and testing, to reduce the transmission of infectious diseases through tissue transplantation. The third final rule establishes current good tissue practices for HCT/Ps. FDA's revised regulations are contained in Part 1271 and apply to tissues recovered after May 25, 2005. The new requirements are intended to improve protection of the public health while minimizing regulatory burden.
CBER also regulates xenotransplantation, which is any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (A) live cells, tissues, or organs from a nonhuman animal source or (B) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs. Xenotransplantation using cells and tissues has been used experimentally to treat certain diseases such as neurodegenerative disorders, liver failure, and diabetes, where human materials are not usually available.
Publications, Presentations and Other Resources
- Exemptions and Alternative Procedures Under 21 CFR Part 1271.155
- FAQs About Tissue Transplants - (CDC)
- Guidances, Rules and Related Documents
- Human Tissue Task Force - 2007 Report
- Keeping Human Tissue Transplants Safe (May/June 2005 FDA Consumer)
- References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies
- Tissue Information Listserv
- Tissue Reference Group
- Tissue Registration
- Tissue Registration Public Query
- Human Cells, Tissues, and Cellular and Tissue-Based Products - CFR Correction - 1/18/2008
- Consumer Frequently Asked Questions (FAQs) - Tissue
- Donor Screening Tests
- Establishment Inspection & Compliance Related Documents
- HCT/P Deviation Reporting
- Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) Adverse Reaction Reporting
- Recalls, Withdrawals, Field Corrections & Notifications
- Safety Information
- Testing HCT/P Donors: Specific Requirements
- Tissue Action Plan