FDA 21 CFR 1271 Regulations

What is 21 CFR 1271?

Human cells, tissues and cellular and tissue-based products (HCT/Ps) are critical in cardiac and reconstructive surgeries, wound closures and many other life-saving medical procedures. The U.S. Food and Drug Administration (FDA) protects the supply of HCT/Ps by enforcing the Current Good Tissue Practice (CGTP) requirements found in 21 CFR Part 1271. CGTP guidelines are aimed at ensuring the safety of HCT/Ps by preventing the introduction, transmission and spread of communicable diseases.

Compliance with FDA's Good Tissue Practices