FDA Reissues Sepsis and Mtb Guidance Documents as Draft for Public Comment

AATB has learned that the US Food and Drug Administration (FDA) has reissued the following guidance documents as drafts, with a public comment period open through July 7, 2025:

• Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by HCT/Ps
• Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by HCT/Ps

AATB is analyzing both documents and will submit comments to the FDA before the July 7 deadline.

This development follows AATB’s ongoing advocacy, including a recent meeting with the White House Office of Management and Budget (OMB), where we formally outlined the tissue banking community’s unified concerns regarding the final guidance documents—originally issued in January 2025 and set to take effect on May 4—including issues of clarity, feasibility, and potential impact on tissue availability. 

AATB is encouraged that the FDA is now seeking broader stakeholder feedback. We will continue to provide timely updates as new information becomes available. Our advocacy remains focused on advancing regulatory approaches that uphold patient safety and practical implementation across the tissue banking community.