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Human Cell and Tissue Product (HCT/P)

Medical products made from human cells or tissues that are used for treatment, diagnosis, or prevention of disease. Examples include skin grafts, bone marrow, and certain types of stem cell therapies.

Tissue Reference Group (TRG)

A group within the Food and Drug Administration (FDA) that provides informal advice and recommendations on how specific human cell and tissue products should be regulated.

Secretary (of Health and Human Services)

The head of the U.S. Department of Health and Human Services, which oversees agencies like the FDA.

Regulatory Oversight

The process by which a government agency, like the FDA, monitors and controls an industry or activity to ensure it follows rules and standards, especially for safety and effectiveness.

Minimal Manipulation

A term used by the FDA to describe how much a human cell or tissue product has been processed or changed from its original state. Products that are 'minimally manipulated' are often subject to less rigorous regulation.

Homologous Use

A term used by the FDA to describe when a human cell or tissue product is used in the recipient for the same basic function as it performed in the donor. Products used for 'homologous use' are often subject to less rigorous regulation.