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Hawk Medical distributes 361 HCT/P products that are minimally manipulated and intended for homologous use under 21 CFR 1271. Compliance support means SOPs and paperwork, not a workaround for unapproved cellular drugs.
Written for licensed providers. Reviewed by Joe Bradley, Founder & CEO. Content version 2026-09-18.
Exclusively 361 HCT/P compliant products from FDA-registered tissue banks. Expert compliance consulting for healthcare providers.
361 is a regulatory lane, not a quality slogan. Minimal manipulation, homologous use, donor screening, lot traceability. We do not distribute products as stem-cell therapy. If you need a 351/BLA story, you are in a different catalog.
Minimal manipulation, homologous use, not combined with another article (with narrow exceptions), and no systemic/metabolic effect relying on living cells as the primary mode. If marketing violates those, the SKU does not save you.
FDA registration and AATB accreditation are vendor questions you should ask on every tissue SKU.
Receiving, storage, adverse-event reporting, and indication language. We help draft; the practice owns the procedure.
Our tissue positioning is 361. Do not assume a BLA product is in the cart.
No. Do not use “FDA approved” as shorthand for 361 HCT/Ps.
FDA for the product; medical boards and FTC for advertising; MACs for billing of related procedures.
We can flag 361 language. Counsel still belongs with your healthcare attorney.
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We own and operate medical clinics, so we understand your real-world challenges
All products meet strict regulatory requirements including HCT/P 361 compliance
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