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Regulatory
PLACENTAL TISSUE SAFETY AND PROCUREMENT
BioXclude is classified by the FDA as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products). HCT/Ps are regulated by the FDA under Section 361 of the Public Services Act. Unlike Medical Devices, Biologics or Drugs, HCT/Ps do not require a 510(k) or Pre-Market Approval, a Biologic License Application Approval or New Drug Application approval.

Rather, HCT/Ps are considered minimally manipulated human tissues which require compliance with the FDA’s Good Tissue Practice guidelines. These guidelines were adopted with the goal of eliminating the transmission of infectious disease. Snoasis Medical adheres to these guidelines.


361 HCT/Ps (Human Cell Tissue/Products)Human Tissue (Allograft)Minimally manipulated, intended for homologous use. No clearance or premarket approval required. Requires FDA Good Tissue Practices (GTP).
510(k) Clearance (351 HCT/Ps)Medical Device (Example:decellularized human dermis, xenografts, collagen dressings, bone void filler).Requires FDA Substantial Equivalence, shorter submission and less required time verses PMA. Based on predicate device. Requires FDA Current Good Manufacturing Practice (cGMP).
Premarket Approval (PMA)Medical Device (Example: human living skin substitutes, bone substitute).Requires extensive FDA premarket approval process, including comprehensive clinical trials. Requires FDA Current Good Manufacturing Practice (cGMP).
Biologic License Application (BLA) (351 HCT/Ps)Biological Product (Example: Cell products, such as those containing heamatopietic progenitor cells, vaccines, and blood components).Requires extensive FDA premarket approval process, including comprehensive preclinical and clinical trials. Requires compliance to FDA Current Good Manufacturing Practice (cGMP).
New Drug Application (NDA)(Example: living stem cells non-autologous, second degree relative, or autologous stem cell that are expanded in the laboratory).Requires extensive FDA premarket approval process, including comprehensive clinical trials. Requires FDA Current Good Manufacturing Practice (cGMP).