REGULATORY UPDATE: AABB, ABC and ARC Submit Comments to FDA on Mtb and Sepsis Guidances
April 08, 2025
AABB, America’s Blood Centers (ABC) and the American Red Cross (ARC) recently submitted two sets of
joint comments to the Food and Drug Administration in response to guidance documents addressing the transmission risk of
Mycobacterium tuberculosis (Mtb) and
sepsis by human cell, tissues and cellular and tissue-based products (HCTPs).
The joint comments reflect the shared priorities and perspectives of the blood and biotherapies community and were developed by AABB Regulatory Affairs in collaboration with ABC and ARC. AABB’s Cellular Therapy Section Coordinating Committee also reviewed the comments.
The comments include the following requests:
- Clarification for handling of false-positive Mtb testing.
- Detailed information and resources for determining “areas of the world where TB is common.”
- Clarification of the signs and symptoms of Mtb infection.
- Consideration that otherwise healthy donors of cellular starting materials (e.g., leukopaks) not be considered at clinical risk of Mtb or sepsis.
- Details on which of the hundreds of potential sepsis-causing pathogens should be prioritized for screening and what constitutes a “suspicion of sepsis.”
FDA extended the implementation date for the two final guidance documents to allow the agency to further evaluate the guidance and review public comments received before the original date. FDA now recommends that facilities implement the recommendations by May 4.
