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Tissue products

Placental tissue

Placental tissue refers to the placenta recovered at delivery. It is a separate tissue source from the umbilical cord and is not part of PB's product catalog.

Placental tissue is not part of PB's product catalog. If evaluating a placental tissue product from another supplier, ask for the exact tissue source and fraction behind the product name.

Ask the supplier directly whether a specific placental tissue product is membrane-derived, fluid-derived or a different fraction, since the product name alone does not specify the source.

Buyers should ask a supplier to specify the exact tissue source and fraction behind any placental tissue product, and should request the donor eligibility summary and processing description for that specific lot rather than inferring composition from the product name alone.

PB does not supply a placental tissue product. If sourcing one from another supplier, confirm the exact anatomical source and fraction before assuming it matches a product from a different supplier.

Sources

  1. 21 CFR 1271.10 - Are my HCT/Ps regulated solely under section 361 of the PHS Act ↗eCFR