America’s Blood Centers, AABB, and the American Red Cross provided this joint response to the FDA’s draft guidance on reducing Mycobacterium tuberculosis (Mtb) transmission risk in human cells, tissues, and cellular and tissue-based products (HCT/Ps). It address key issues such as the limitations of Mtb testing, the need for clearer definitions of TB risk factors, alternative screening methods for healthy donors, and special considerations for domino transplants. These insights highlight the delicate balance between ensuring product safety and maintaining an adequate supply of life-saving cellular therapies. This comprehensive response provides invaluable technical details, expert recommendations, and nuanced arguments that are essential for understanding the complexities of Mtb risk mitigation in HCT/Ps and shaping effective safety policies in this critical field.
