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

1 November 2022 – FDA published the final Small Entity Compliance guidance on HCT/Ps regulations.

The FDA has prepared this 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.

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