Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide

Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).  It is intended to help small entity establishments that manufacture  human cells, tissues, or cellular or tissue-based products (HCT/Ps) better understand the comprehensive regulatory framework for HCT/Ps, set forth in Title 21 of the Code of Federal Regulations, part 1271 (21 CFR 1271).  Section 21 CFR 1271.3 provides definitions for important terms used in 21 CFR 1271.