Publication of three FDA draft guidelines on donor eligibility for HCT/Ps

The FDA has published three draft guidelines that update requirements and recommendations for determining donor eligibility for human cells, tissues, and cell-based products (HCT/Ps) under 21 CFR to further reduce the risk of transmission of human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV). This guideline applies to donations collected from 25 May 2005 onwards and contains the following significant changes:

1. HIV risk:

• Reduction of certain time-based risk factors and conditions for donor selection.
• Introduction of standardised, individual risk-based questions for all donors, regardless of gender or gender identity.
• Replace previous recommendations for HIV-1 Group O risk assessment with a requirement for an FDA-approved screening test that detects HIV-1 Group O.

2. HCV risk:

• Adjust donor selection by reducing certain time-based risk factors and conditions.
• Apply the same individual risk-based questions to all donors, regardless of gender or gender identity, to assess HCV risk.

3. HBV risk:

• Inclusion of the recommendations from the 2016 guideline on nucleic acid testing (NAT) to minimise the risk of HBV transmission.
• Standardised, individual risk-based questions for all donors to assess HBV risk.
• Adaptation of screening and testing requirements, including the use of NAT to improve detection of HBV infection.

These changes will introduce specific, more stringent donor screening and testing requirements that will be applied uniformly to all donors. The aim is to increase the safety of human cells, tissues and cellular and tissue-based products (HCT/Ps) by using more reliable testing methods and more comprehensive risk assessments. The new guideline replaces previous versions and provides clearer guidance to minimise the transmission risks of HIV, HCV and HBV. If you are interested, read the full drafts of the FDA guidance for reducing the risk of transmission of HIV, HBV and/or HCV.