AATB Submits Formal Comments on FDA Draft Guidance for Sepsis and MTB

July 7, 2025

Today, AATB submitted formal comments to the Food and Drug Administration (FDA) in response to the draft guidance documents issued on May 2, 2025: 

These comments reflect significant input from the AATB Physician’s Council and the Scientific and Technical Affairs Committee. AATB will continue engaging with the FDA to advocate that any final guidance documents are scientifically sound and support both the safety and availability of tissue products for patients in need. 
 

Sepsis Draft Guidance
AATB challenges FDA’s classification of sepsis as a relevant communicable disease agent or disease (RCDAD). In our comments, we urge FDA to rescind the current draft guidance and instead develop guidance focused more broadly on systemic infections.

Sepsis does not meet the FDA’s own criteria for an RCDAD, nor do the definitions currently in use for the term support its classification as a transmissible disease. AATB’s comments emphasize that sepsis is a dysregulated immune response to systemic infection, not the infection itself. The critical question is whether an underlying infection is present and transmissible, and not whether the donor was diagnosed with sepsis. 

AATB’s comments also outline several practical concerns associated with this classification, including inconsistent definitions of sepsis, the influence of reimbursement incentives on diagnostic practices, and how electronic medical record have contributed to increased documentation of sepsis diagnoses since it was first designated as an RCDAD in 2007. 
 

MTB Draft Guidance
AATB continues to have serious concerns about the feasibility and reliability of testing for Mycobacterium tuberculosis (MTB) as outlined in the draft guidance. While a validated, accurate testing method could eventually support risk mitigation, the currently available tests are not suitable for this purpose. 

Our comments also emphasize that we interpret the agency’s language on product testing as advisory rather than as a mandate or basis for enforcement. In the meantime, AATB is leading a collaborative industry-wide initiative to develop evidence-based criteria and guidance to help assess MTB risk and explore future testing strategies.
 

Next Steps
AATB remains committed to supporting regulatory approaches that prioritize patient safety while enabling practical implementation for the tissue banking community. You can read AATB’s full comments and find all related advocacy communications on the Government Advocacy Correspondences page of the AATB website.