FDA Releases Six Guidance Documents Affecting Human Tissue for Transplantation

January 6, 2025

On January 6, 2025, the FDA published 6 guidance documents that will affect AATB tissue establishments. These six documents address various aspects of donor eligibility and risk reduction for communicable diseases and are as follows:

Focus on Final Guidance Documents 
Two of these documents - Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by HCT/Ps (Sepsis guidance) and Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by HCT/Ps (Mtb guidance) - have been issued as final guidance documents. While final, public comments are still welcomed per federal regulations. AATB will provide members with an opportunity to inform and shape the industry’s response. 
 
The recommendations in these guidance documents focus on: 

  • Screening for risk factors and conditions of sepsis and Mtb infection. 
  • Screening for clinical and physical evidence of sepsis and Mtb infection. 
  • Testing for evidence of sepsis and Mtb infection.  

FDA Implementation Deadline: The FDA expects tissue establishments to implement recommendations from the Sepsis and Mtb guidance documents by February 3, 2025. AATB will be addressing concerns regarding this implementation date with the FDA.
 
Next Steps: We Want to Hear From You
AATB is convening the Physician Council Sepsis Working Group and Mtb Working Group, as well as the TPG Regulatory/Quality Monitoring Working Group, to conduct a comprehensive review of all six documents and will share additional information with the membership when available. Recognizing the operational impact of these changes, AATB will seek clarity from the FDA on issues raised in the guidance documents.
 
Your Input Matters: AATB is gathering feedback to provide to the FDA. Members with questions or concerns are encouraged to submit comments to aatb@aatb.org.