GUIDANCE DOCUMENT
Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft Guidance for Industry January 2025
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2022-D-0466
- Issued by:
-
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
On January 6, 2025, FDA announced the availability of draft guidance documents on donor eligibility recommendations to reduce the risk of transmission of Hepatitis B Virus, Hepatitis C Virus, and Human Immunodeficiency Virus by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. Please note, these draft guidance documents are not for implementation and are for comment purposes only.
For a high-level overview of these guidance documents, please view this recorded webinar featuring Dr. Irma Sisson, Division of Human Tissues, Office of Cellular Therapy and Human Tissues, Office of Therapeutic Products, CBER.
Additionally, view these related resources to learn more about FDA’s recently published draft guidance document on recommendations for determining eligibility of donors for HCT/Ps and find links to other relevant guidance documents.
We, FDA or Agency, 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 applies to human cells and tissues recovered on or after May 25, 2005, the effective date of the regulations contained in 21 CFR part 1271, subpart C, and provides recommendations to reduce the risk of transmission of hepatitis C virus (HCV) by HCT/Ps. This guidance updates information regarding HCV risk included in the guidance entitled “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry,” dated August 2007 (August 2007 HCT/P DE Guidance), by revising recommendations for: 1) donor screening that includes reducing certain time-based risk factors and conditions, and 2) assessing every HCT/P donor for HCV risk using the same individual risk-based questions for every donor regardless of sex.
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-2022-D-0466.