Tissue and 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.
Examples of HCT/Ps:
Bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes and semen.
Vascularized human organ transplants such as kidney, liver, heart, lung or pancreas. Health Resources Services Administration (HRSA) has oversight of vascularized human organ transplantation.
21 CFR Parts 1270 and 1271 require that tissue establishments screen and test donors, prepare and follow written procedures for the prevention of the spread of communicable disease, and to maintain records. FDA has published 3 final rules that serve to broaden the scope of products subject to regulation, as well as to include more comprehensive requirements to prevent introduction, transmission, and spread of communicable disease:
- Requirement of firms to register and list their HCT/Ps with FDA
- Requirement of tissue establishments to evaluate donors, through screening and testing, to reduce the transmission and spread of communicable disease
- Establishment of current good tissue practices for HCT/Ps
FDA’s revised regulations are contained in CFR Part 1271, and apply to all tissues recovered after May 25, 2005.
FDA HCT/P Product List:
Further information is available at: