Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure 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 2Failure to collect a donor specimen for testing for relevant communicable diseases at the time of recovery of cells or tissue from the donor; or for oocyte donors, up to 30 days before recovery or up to seven days after recovery [21 CFR 1271.80(b)]. For example, a specimen for communicable disease testing was collected from anonymous oocyte donor **(b)(6),** **(b)(7)(C)** on **(b)(6),** **(b)(7)(C)**. However, oocytes were recovered from the donor on **(b)(6),** **(b)(7)(C)**.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271
- 21 CFR 1271.60(a)
- 21 CFR 1271.155
- 21 CFR 1271.75(a)
- 21 CFR 1271.3(s)
- 21 CFR 1271.80(b)
- 21 CFR 1271.45
- 21 CFR 1271.47
- 21 CFR 1271.50(a)
- 21 CFR 1271.75
- 21 CFR 1271.80
- 21 CFR 1271.47(a)
- 21 CFR 1271.90(b)
- 21 CFR 1271.90(c)