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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

Download the Final Guidance Document Read the Federal Register Notice
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).

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All written comments should be identified with this document's docket number: FDA-2016-D-3750.

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