Informational Session: The Recent FDA Guidances – Analysis and Discussion

EBAA discusses the guidance documents released by FDA on January 6, 2025. We discuss the new regulations and implementation timelines, describe what steps EBAA is taking to mitigate their impact, and illustrate how eye banks can submit comments to FDA. 

This presentation was recorded live on January 22, 2025. 

FDA Guidances

Here are the FDA Guidances released on January 6, 2025. These are the guidances that are discussed in the webinar.

Final Guidance

• 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
• 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

Draft Guidance for Comment

• Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
• 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of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
• 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of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
• 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of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry