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


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
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, and cellular and tissue-based products (HCT/Ps) better understand and comply with the comprehensive regulatory framework for HCT/Ps, set forth in Title 21 of the Code of Federal Regulations, Part 1271 (21 CFR Part 1271). Title 21 CFR 1271.3 provides definitions for important terms used in 21 CFR Part 1271.

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