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 7341.002 - Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (Covers HCT/Ps recovered after 5/25/2005) 7341.002A - Inspection of Tissue Establishments (Covers human tissue recovered before 5/25/2005) 7342.007 - Imported CBER-Regulated Products[ARCHIVED] 7342.007 Addendum - Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) FDA Forms Task Force on Human Tissue Safety[ARCHIVED] Human Tissue Task Force 2007 Report FDA Public Health Notification: Vista Cord, LLC[ARCHIVED] Order to Cease Manufacturing of HCT/Ps - Vista Cord, LLC[ARCHIVED] 9/24/2009 FDA Public Health Notification: Donor Referral Services[ARCHIVED] 8/30/2006 FDA Orders Donor Referral Services and Philip Guyett to Cease Manufacturing Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and to Retain HCT/Ps[ARCHIVED] Order to Cease Manufacturing and to Retain HCT/Ps - Biomedical Tissue Services, Ltd[ARCHIVED] 2/6/2006 Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005 - 2006 (CDC) 5/26/2006 HCT/P Inspection Information Recalls (Biologics)
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
Good Tissue Practices & Reporting
Exemptions and Alternative Procedures Biological Product Deviations
Human Cell & Tissue Products (HCT/P) Deviation Reporting
Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting