21 CFR 1271.50
How do I determine whether a donor is eligible?
21 CFR 1271.50 is the regulation titled “How do I determine whether a donor is eligible?” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 9 FDA warning letters have cited it.
- Letters citing it
- 9 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.155, in 8 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are biologics letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 1271.50 most often, as written in the letters.
- 2 lettersFailure of a responsible person to determine and document the eligibility of a cell or tissue donor [21 CFR 1271.50(a)]. For example:
- 1 letterFailure of a responsible person to determine and document the eligibility of a cell or tissue donor based upon the results of donor screening and donor testing [21 CFR 1271.50(a)].** For example:
- 1 letterFailure of a responsible person to determine and document the eligibility of a donor of reproductive cells or tissue based on the results of donor screening and testing [21 CFR 1271.50(a)]. For example, the records for…
The regulation
Read the text of 21 CFR 1271.50 (eCFR, as of Sep 1, 2026)
(a) Determination based on screening and testing. If you are the establishment responsible for making the donor-eligibility determination, you must determine whether a donor is eligible based upon the results of donor screening in accordance with § 1271.75 and donor testing in accordance with §§ 1271.80 and 1271.85. A responsible person, as defined in § 1271.3(t), must determine and document the eligibility of a cell or tissue donor.
(b) Eligible donor. A donor is eligible under these provisions only if:
(1) Donor screening in accordance with § 1271.75 indicates that the donor:
(i) Is free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases; and
(ii) Is free from communicable disease risks associated with xenotransplantation; and
(2) The results of donor testing for relevant communicable disease agents in accordance with §§ 1271.80 and 1271.85 are negative or nonreactive, except as provided in § 1271.80(d)(1).
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.50.
- 21 CFR 1271.155Exemptions and alternatives8 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?8 letters cite both
- 21 CFR 1271.60What quarantine and other requirements apply before the donor-eligibility determination is complete?8 letters cite both
- 21 CFR 1271.75How do I screen a donor?8 letters cite both
- 21 CFR 1271.90Are there other exceptions and what labeling requirements apply?8 letters cite both
- 21 CFR 1271.80What are the general requirements for donor testing?7 letters cite both
- 21 CFR 1271.85What donor testing is required for different types of cells and tissues?7 letters cite both
- 21 CFR 1271.45What requirements does this subpart contain?5 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 1271.50 that FDA posted most recently.
- BiologicsView Central Coast Multispecialty Medical Group, Inc.human cells, tissues, and cellular and tissue-based products (HCT/Ps)IssuedJan 29, 2026PostedFeb 10, 2026
- BiologicsView Conceive Fertility Centerreproductive cells or tissue (oocytes and semen)IssuedJan 27, 2026PostedFeb 10, 2026
- BiologicsView Green Valley Fertility Partnershuman cells, tissues, and cellular and tissue-based products (HCT/Ps)IssuedDec 3, 2025PostedDec 16, 2025
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