Allografts have been used across many tissue types, including bone, skin and cornea, through long-established tissue banking practice that predates cord-tissue products by decades. The category is defined by tissue origin, donor to recipient, not by any specific processing method or product family.
Allografts derived from human tissue generally fall under the FDA's human cells, tissues, and cellular and tissue-based products (HCT/P) framework. Whether a specific intended use meets all applicable criteria in 21 CFR 1271.10, including minimal manipulation, homologous use, and the condition concerning living-cell metabolic activity, is a determination made for each product and intended use, to be reviewed with counsel.
Before purchasing from any allograft supplier, request establishment registration documentation, donor eligibility records, and a lot-specific certificate of analysis. The word "allograft" alone does not establish FDA approval or clearance, and no HCT/P product described in this glossary is represented as FDA approved. These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
The term describes tissue origin, not regulatory status, so buyers should always verify documentation rather than assume "allograft" implies FDA clearance.