All BioIntegrate injectable products are categorized as Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/P’s) under Section 361. Currently, the FDA regulates all biological regenerative products under this Section. BioIntegrate products are processed from donated non-embryo human tissue from full term deliveries and regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service. They are in compliance with the FDA guidelines and are minimally manipulated, intended only for homologous use.