A donor eligibility determination based on screening and testing for relevant communicable agents and diseases is required for all donors of cells or tissue used in human cells, tissues and cellular and tissue-based products (HCT/Ps).
Infectious disease testing for donor eligibility must be performed in an FDA-registered laboratory using tests that have been licensed, approved, or cleared by the FDA specifically for use in donor screening (when available) or approved/cleared for use in low-prevalence, asymptomatic populations.