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GUIDANCE DOCUMENT

Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft Guidance for Industry January 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-0464
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

On January 6, 2025, FDA announced the availability of the draft guidance document, “Recommendations for Determining Eligibility of Donors of HCT/Ps” (DRAFT – Not for Implementation). Please note, this guidance document is for comment purposes only.

For a high-level overview of this guidance document, please view this recorded webinar featuring Dr. Simone Porter, Human Tissue/Reproduction Branch, Division of Human Tissues, Office of Cellular Therapy and Human Tissues, Office of Therapeutic Products, CBER.

Additionally, view this related recorded webinar to learn more about FDA’s recently published draft guidance documents on donor eligibility recommendations to reduce the risk of transmission of Hepatitis B Virus, Hepatitis C Virus, and Human Immunodeficiency Virus by HCT/Ps. 

We, FDA, are issuing this guidance to assist you, establishments making donor eligibility determinations, in understanding the requirements in Title 21 Code of Federal Regulations, part 1271, subpart C (21 CFR part 1271, subpart C).  The regulations under 21 CFR part 1271, subpart C set out requirements for determining donor eligibility, including donor screening and testing, for donors of human cells, tissues, or cellular or tissue-based products (HCT/Ps).

This guidance includes general information on determining eligibility for donors of HCT/Ps.  FDA also intends to issue separate guidance documents with recommendations regarding reducing the risk of transmission of specific communicable disease agents and diseases for donors of HCT/Ps as follows:  human immunodeficiency virus, hepatitis B virus, hepatitis C virus, Mycobacterium tuberculosis (Mtb), sepsis, human transmissible spongiform encephalopathies, cytomegalovirus, Chlamydia trachomatis and Neisseria gonorrhoeae, human T-lymphotropic virus, Treponema pallidum (syphilis), vaccinia virus, West Nile virus, and communicable disease risks associated with xenotransplantation.  

Submit Comments

Submit Comments Online

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-2022-D-0464.

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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