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
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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).
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:
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.