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GUIDANCE DOCUMENT

Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide Guidance for Industry August 2007

Download the Final Guidance Document
Final
Docket Number:
FDA-1998-N-1016
Issued by:
Guidance Issuing Office
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, 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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1998-N-1016.

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