Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide Guidance for Industry November 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2022-D-0563
• Issued by: Center for Biologics Evaluation and Research

The Food and Drug Administration (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. 

This guidance document supersedes the guidance of the same title dated August 2007.

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