Tissue and Tissue Products
The Center for Biologics Evaluation and Research (CBER) regulates human cells and tissue intended for implantation, transplantation, infusion, or transfer into a human recipient. Examples of tissue and tissue products may include bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes, and semen.[1] CBER does not regulate the transplant of vascularized human organs such as the kidney, liver, heart, lung, or pancreas—these are regulated by the Health Resources Services Administration.
FDA Resources
- Tissue Guidance
- FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products Product List
Updated by Peter Matos, December 2023
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