Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm’sDonor Eligibility Questionnaire and Donor Medical History Interview Form areused as relevant medical records to determine donor eligibility. However, yourforms do not include screening for all conditions and/or behaviors that increase adonor’s relevant communicable disease risk.
Passage 2For example, directed semen donor **(b)(6)** answered "yes" to question 1 on your *Donor Medical History Interview Form*, "(Men only) Have you had sex with another man in the preceding five years?" Donor **(b)(6)** was determined “eligible” on May 9, 2025.
Passage 3The eligibility of donor **(b)(6)** was determined and documented prior to the receipt of the results of donor testing for relevant communicable disease agents.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271
- 21 CFR 1271.75(a)(1)
- 21 CFR 1271.80
- 21 CFR 1271.60(a)
- 21 CFR 1271.155
- 21 CFR 1271.75(d)
- 21 CFR 1271.75
- 21 CFR 1271.85
- 21 CFR 1271.50(a)
- 21 CFR 1271.65(b)(2)
- 21 CFR 1271.90
- 21 CFR 1271.75(a)
- 21 CFR 1271.3(l)
- 21 CFR 1271.90(b)
- 21 CFR 1271.90(c)