FDA released four draft and two final tissue guidances on January 6, 2025, for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
- Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
1/2025 - Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
1/2025 - 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of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
1/2025 - Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
1/2025 - Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry
1/2025 - Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry
1/2025
EBAA will be hard at work analyzing these guidances and submitting comments on behalf of the membership.
The draft guidances are issued for comment purposes only and should not be implemented yet. FDA recommends that you implement the recommendations in the Mycobacterium tuberculosis and Sepsis guidances as soon as feasible, but not later than 4 weeks after the guidance issue date.
These HCT/P guidance documents were posted on the FDA’s Tissue Guidances website and can also be reached via FDA’s What’s New for Biologics website.