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Understand tissue allografts: what they are, how they work, and FDA compliance. Educational guide for healthcare providers.
Tissue allografts are human tissue products processed for therapeutic use. They come from donated tissue—typically umbilical cord, amniotic membrane, or other sources—and are processed to preserve their regenerative properties. Under FDA regulations, HCT/P 361 products must be minimally manipulated and used for homologous purposes. Understanding these requirements is essential for any practice offering tissue allografts.
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