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GUIDANCE DOCUMENT

Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates Guidance for Industry November 2016

Final
Docket Number:
FDA-2016-D-3750
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance provides you, establishments that make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with information on infectious-disease risks related to receipt of FDA licensed human-derived clotting factor concentrates (HDCFCs). This guidance explains that FDA no longer considers FDA licensed HDCFCs as a risk factor for Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV). As such, receipt of FDA licensed HDCFCs, or sex with a person who has received FDA licensed HDCFCs, should not be considered a risk factor when determining eligibility of a donor of HCT/Ps. This guidance supplements the recommendations regarding HDCFCs that are contained 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 Guidance).


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-2016-D-3750.

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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