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.
Leave A Comment