FDA Compliance Q&A

---

“As defined in 21 CFR 1271.3(f), minimal manipulation means 1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement; 2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.”

Our proprietary process does not alter the original relevant characteristics of the tissue, nor does it involve the isolation of any components found within the original tissue. Our specialized technicians carefully resize and suspend the tissue in saline with added chryo preservative, which is expressly permitted by the FDA.

During our manufacturing process, the donated umbilical tissue, or Wharton’s jelly, is disassociated and reduced to a size that sufficiently maintains its ability to perform its primary structural function. Using Microscopy, the original relevant characteristics are observed in both the donor tissue and the final product

“As defined in 21 CFR 1271.3(c), homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.”

“In applying the homologous use criterion, the FDA will determine what the intended use of the HCT/P is, as reflected by the labeling, advertising, and other indications of a manufacturer’s objective intent, and will then apply the homologous use definition.”

The primary function of Wharton’s jelly is well established in scientific literature as providing cushioning and structural support. Wharton’s jelly in the umbilical cord serves to cushion and protect internal structures (the vein and arteries) from mechanical stress. When transplanted into a soft tissue defect, our product performs the same original functions as in the umbilical cord of cushioning and supporting surrounding tissues.