News & Publications

FDA Issues Final Guidance on Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells

January 11 , 2012
by: ASRM Office of Public Affairs
Published in ASRM Bulletin Volume 14, Number 3

The U.S. Food and Drug Administration has issued final guidance and has announced the availability of a document entitled ‘‘Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).’’ This guidance finalizes the draft guidance of the same title dated January 2009.

The guidance provides recommendations for complying with the CGTP requirements under part 1271 (21 CFR part 1271), subpart D, and additional requirements for manufacturers of HCT/Ps under part 1271, subpart E. The guidance is intended for any HCT/P establishment that performs a manufacturing step and is responsible for complying with CGTP requirements. However, at this time, part 1271, subpart D (with the exceptions of sections 1271.150(c) and 1271.155) and subpart E do not apply to reproductive HCT/P establishments regulated solely under section 361 of the Public Health Service Act (42 U.S.C.264).

To access the guidance go to: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/default.htm 

For questions on the content of this guidance, contact the FDA’s Office of Communication, Outreach and Development at 1-800-835-4709 or 301-827-1800, or ocod@fda.hhs.gov.


The ASRM Bulletin is published by ASRM's Office of Public Affairs to inform Society members of important recent developments. Republication or any other use of the contents of the Bulletin without permission is prohibited. To request permission to quote or excerpt material from the Bulletin, contact Sean Tipton at stipton@asrm-dc.org.   

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Email: stipton@asrm-dc.org

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