Tissue & Tissue Products

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.

Compliance & Inspection

• FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P's) Product List - ARCHIVED
• 7342.007: Imported CBER-Related Products
• 7342.007 Addendum: Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
• Human Tissue Task Force 2007 Report - ARCHIVED
• Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005 - 2006 (CDC)
  5/26/2006
• Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Inspection Information

Donor Testing

• Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases
• Testing Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P): Specific Requirements

Establishment Registration

• Tissue Establishment Registration
• Human Cell and Tissue Establishment Registration (HCTERS) Public Query Application
  Search the database for information on Registered Human Cell and Tissue Establishments

General Information

• Information for Health Professionals on "Partial Heart Transplantation"
• Cord Blood Banking - Information for Consumers
• Tissue and Tissue Product Questions and Answers
• Tissue Safety & Availability
• References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies

Good Tissue Practice & Reporting

• Exemptions and Alternatives
• Biological Product Deviations
  Human Cell & Tissue Products (HCT/P) Deviation Reporting
• Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting

Publications & Other Resources

• Tissue Guidances
• Tissue Notices, Proposed and Final Rules
• Tissue Reference Group
• Cellular, Tissue, and Gene Therapies Advisory Committee

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Related Information

• Transplant Safety - Centers for Disease Control and Prevention (CDC)

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