FDA/CBER Published Six New Donor Screening Guidance Documents

On 06 January 2025, FDA/CBER posted new guidance documents that provide updated recommendations for screening donors of human cells, tissues, or cellular or tissue-based products (HCT/Ps) for risks associated with transmission of HIV, HBV, HCV, and the disease agents associated with sepsis. In addition, a separate guidance document identifies Mycobacterium tuberculosis as a new relevant communicable disease agent or disease (RCDAD) for donors of HCT/Ps, and a general donor eligibility guidance document was updated that was previously published in 2007. All six guidance documents can be accessed at this link.