21 CFR 1271 Subpart C - Donor Eligibility

What it says

Donors of human cells, tissues, and cellular and tissue-based products must be screened and tested for relevant communicable disease agents and risk factors, with a documented eligibility determination made and recorded before the donated material is used, except in specifically defined exception circumstances.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Donor eligibility determination is the upstream gatekeeping step that the current good tissue practice requirements in 21 CFR 1271 Subpart D are built on, since no amount of downstream processing control can compensate for using material from an ineligible donor.
• Screening and testing must be completed and the eligibility determination documented before the product is used, meaning timing matters as much as content, a determination made after the fact does not satisfy the requirement.
• The specific exceptions permitting use of ineligible-donor material are narrowly defined and typically require additional labeling and documentation, so relying on an exception without meeting its specific conditions is itself a compliance gap.

What FDA inspectors look for

• Whether a documented donor eligibility determination exists for each donor and was completed before the donated material was used.
• Whether screening and testing records are complete and address all required communicable disease agents and risk factors.
• Whether any use of ineligible-donor material relied on a properly documented and labeled exception rather than an undocumented shortcut.

Related regulations