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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

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 This guidance finalizes the draft guidance of the same title dated January 2009.


Submit Comments

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.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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