REGULATORY UPDATE: FDA Outlines Risk Mitigation Strategies Concerning TB and HCT/P Donation; AABB Releases Accompanying Toolkit

September 11, 2023

In response to a recent tuberculosis outbreak that appears to be linked to a bone matrix product, the Food and Drug Administration issued a safety and availability communication on Sept. 6 to increase awareness of the risk of Mycobacterium tuberculosis (Mtb) transmission through use of human cell, tissue and cellular and tissue-based products (HCT/P) in the United States.

FDA’s August 2007 guidance outlines routine screening measures to evaluate clinical evidence of infection in HCT/P donors and reduce the risk of transmission of infections, including sepsis (which may be caused by Mtb). However, the agency shared additional risk mitigation strategies concerning Mtb that are important for public health safety. These strategies address the HCT/P establishment’s responsible person (21 CFR 1271.3[t]), donor screening and donor testing.

FDA also reiterated that the agency continues to work with the Centers for Disease Control and Prevention to assess the most recent outbreak and to look for ways to prevent transmission of Mtb from HCT/Ps going forward. The agency will communicate additional information as it becomes available.

FDA used this type of communication during the COVID pandemic to provide blood collection facilities with optional measures that could be considered by the responsible medical director. The risk mitigation strategies outlined in the Mtb communication have not been issued as formal recommendations in guidance.

To support members with questions, AABB contacted FDA to confirm that the association correctly understands FDA to be providing risk mitigation strategies applicable to all donors of HCT/Ps, as defined in 21 CFR 1271.3(d), including hematopoietic stem/progenitor cells (HPCs) derived from peripheral and cord blood. 

In addition, AABB developed a toolkit, “AABB Resources to Support FDA’s Voluntary Tuberculosis Risk Mitigation Strategies for HCT/P Establishments,” to supplement member understanding of the agency’s Sept. 6 safety and availability communication. The toolkit provides an overview of the important information from FDA on the investigation of the outbreak and voluntary risk mitigation strategies.

Those with questions may contact AABB Regulatory Affairs