REGULATORY UPDATE: FDA Releases HCT/P Guidance Documents Related to Donor Eligibility

In addition, the agency issued three separate guidance documents with recommendations to reduce the risk of transmission of specific communicable disease agents and diseases for donors of HCT/Ps, including HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV). Finally, FDA published two final guidance documents with screening and testing recommendations for Mycobacterium tuberculosis and sepsis. 

In the future, FDA also intends to issue separate additional guidance documents with recommendations regarding reducing the risk of transmission of  human transmissible spongiform encephalopathies, cytomegalovirus, Chlamydia trachomatis and Neisseria gonorrhoeae, human T-lymphotropic virus, Treponema pallidum (syphilis), vaccinia virus, West Nile virus, and communicable disease risks associated with xenotransplantation.

Following a multi-state outbreak of Mycobacterium tuberculosis (Mtb), the organism that causes tuberculosis, in recipients of allograft bone products, FDA issued two guidances for immediate implementation that focus on donor screening for Mtb and sepsis. The agency recommends that facilities implement the updates no later than four weeks after their issue date. 

The Mtb guidance identifies Mtb as a relevant communicable disease agent or disease (RCDAD) under 21 CFR 1271.3(r)(2). It provides recommendations for:

Similarly, the sepsis guidance updates recommendations for donor eligibility determinations related to clinical signs and risk factors for sepsis. It includes screening for risk factors and conditions associated with sepsis, screening for clinical and physical evidence of sepsis and testing for evidence of sepsis.

Individual Donor Assessment

In the draft guidance for industry “Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by HCT/Ps,” FDA proposes to expand HCT/P donor eligibility using an individual donor assessment approach similar to that implemented in May 2023 for blood donors.  

Under the draft guidance, FDA proposes to reduce certain time-based deferrals and instead assess HCT/Ps donors for HIV risk using individual risk-based questions, regardless of sex or gender.

As with blood donors, FDA recommends that establishments deem ineligible any potential HCT/P donors taking medications to prevent HIV infection — such as pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) — as these treatments may delay HIV detection in currently licensed screening tests.

Additionally, the agency recommended the use of an FDA-licensed donor screening test that includes detection of anti-HIV-1 group O and removed the recommendation to screen HCT/P donors for HIV-1 group O risk.  

FDA also revised guidance documents on HBV and HCV risk among HCT/P donors, aligning these donor screening recommendations with individual donor assessment. 

All three guidance documents supersede the August 2007 HCT/P donor eligibility guidance, and the HBV guidance also supersedes the August 2016 guidance entitled “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.” 

FDA stated that, “When the general guidance and the associated specific guidances are finalized, FDA intends to collate information from the guidances and provide comprehensive lists of recommendations on the FDA website regarding conditions and behaviors that increase the donor’s relevant communicable disease risk, examples of clinical evidence or relevant communicable disease or high-risk behavior associated with these diseases, disease agents for which all donors of HCT/Ps must be tested, and the types of tests we currently consider to be adequate and appropriate to meet the requirements of 21 CFR 1271.80(c).”