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GUIDANCE DOCUMENT

Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Guidance for Industry December 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA–2008–D–0659
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are issuing this guidance to provide you, establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations for complying with Current Good Tissue Practice (CGTP) requirements under Title 21 Code of Federal Regulations, Part 1271 (21 CFR Part 1271), Subpart D (Subpart D)1, and requirements under Part 1271, Subpart E. This guidance also addresses whether the establishment registration and HCT/P listing requirements under Part 1271, Subparts A and B (Subparts A and B) apply in certain instances. This guidance finalizes the draft guidance of the same title dated January 2009.

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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–2008–D–0659.

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