Washington Fertility Center

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to screen a donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)]. FDA’s regulations at 21 CFR 1271.3(s) define the term “relevant medical records” to include a current donor medical history interview and a current report of the physical examination of a living donor. For example:

Passage 2

Failure of a responsible person to determine and document the eligibility of a cell or tissue donor [21 CFR 1271.50(a)]. For example:

Passage 3

Failure to establish and maintain procedures for all steps performed in testing, screening, determining donor eligibility, and complying with all other requirements of Subpart C “Donor Eligibility” in 21 CFR Part 1271.45-1271.90. “Establish and maintain” means define, document, and implement; then follow, review, and as needed, revise on an ongoing basis [21 CFR 1271.47(a)]. For example:

Passage 4

Failure to establish and maintain a procedure governing the release of an HCT/P from a donor whose specimen tests reactive for cytomegalovirus (CMV) [21 CFR 1271.85(b)(2)].