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Tissue allografts are donated human tissues processed for homologous use. Under 361 HCT/P rules they must be minimally manipulated. Hawk Medical sources from FDA-registered banks and expects clinics to file lots.
Written for licensed providers. Reviewed by Joe Bradley, Founder & CEO. Content version 2026-09-18.
Understand tissue allografts: what they are, how they work, and FDA compliance. Educational guide for healthcare providers.
Allograft here means donated tissue processed by an FDA-registered bank, used homologously. Ask for registration, AATB status where relevant, and the IFU. Bank location is not our clinic address.
Allograft ≠ PRP. Explain that to patients who think everything regenerative is “their own cells.”
Processing that alters original relevant characteristics can kick a product out of 361. That is a bank/regulatory fact, not a slogan.
Different tissues, different IFUs. Do not treat them as one juice.
Screened donors via registered banks.
Screening and processing reduce risk; it is not zero — counsel per IFU.
Patient-specific; the clinic consents.
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