FDA Guidance for Industry
RichSource product line RichGen is regulated as a human cellular or tissue-based product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Act, FDA and ISO 13485 guidelines. FDA registered, inspected and cGMP compliant.
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Title 21 – Food and Drugs Part 1271.10 – Human Cells, Tissues, and Cellular and Tissue- Based Products - HCT/P’s
AATB Guidance Documents
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
Title 21 – Current Good Tissue Practice Sec. 1271.150
Current Good Manufacturing Practice Regulations cGMP
Quality and Safety Assured at Our Tissue Bank
