21 CFR 1271.75
How do I screen a donor?
21 CFR 1271.75 is the regulation titled “How do I screen a donor?” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 18 FDA warning letters have cited it.
- Letters citing it
- 18 since 2021
- Jan 1 to Oct 30, 2026
- 4 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.3, in 13 letters
- Closed out
- 11% 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 1271.75 most often, as written in the letters.
- 2 lettersFailure 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…
- 1 letterBetween January 2021 and January 2024, you failed to determine as ineligible five donors of ocular HCT/Ps with a documented diagnosis or clinical evidence of sepsis, including two or more systemic responses to…
- 1 letterFailure to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required under 21 CFR…
The regulation
Read the text of 21 CFR 1271.75 (eCFR, as of Sep 1, 2026)
(a) All donors. Except as provided under § 1271.90, if you are the establishment that performs donor screening, you must screen a donor of cells or tissue by reviewing the donor's relevant medical records for:
(1) Risk factors for, and clinical evidence of, relevant communicable disease agents and diseases, including:
(i) Human immunodeficiency virus;
(ii) Hepatitis B virus;
(iii) Hepatitis C virus;
(iv) Human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease;
(v) Treponema pallidum; and
(2) Communicable disease risks associated with xenotransplantation.
(b) Donors of viable, leukocyte-rich cells or tissue. In addition to the relevant communicable disease agents and diseases for which screening is required under paragraph (a) of this section, and except as provided under § 1271.90, you must screen the donor of viable, leukocyte-rich cells or tissue by reviewing the donor's relevant medical records for risk factors for and clinical evidence of relevant cell-associated communicable disease agents and diseases, including Human T-lymphotropic virus.
(c) Donors of reproductive cells or tissue. In addition to the relevant communicable disease agents and diseases for which screening is required under paragraphs (a) and (b) of this section, as applicable, and except as provided under § 1271.90, you must screen the donor of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for and clinical evidence of infection due to relevant communicable diseases of the genitourinary tract. Such screening must include screening for the communicable disease agents listed in paragraphs (c)(1) and (c)(2) of this section. However, if the reproductive cells or tissues are recovered by a method that ensures freedom from contamination of the cells or tissue by infectious disease organisms that may be present in the genitourinary tract, then screening for the communicable disease agents listed in paragraphs (c)(1) and (c)(2) of this section is not required. Communicable disease agents of the genitourinary tract for which you must screen include:
(1) Chlamydia trachomatis; and
(2) Neisseria gonorrhea.
(d) Ineligible donors. You must determine ineligible a donor who is identified as having either of the following:
(1) A risk factor for or clinical evidence of any of the relevant communicable disease agents or diseases for which screening is required under paragraphs (a)(1), (b), or (c) of this section; or
(2) Any communicable disease risk associated with xenotransplantation.
(e) Abbreviated procedure for repeat donors. If you have performed a complete donor screening procedure on a living donor within the previous 6 months, you may use an abbreviated donor screening procedure on repeat donations. The abbreviated procedure must determine and document any changes in the donor's medical history since the previous donation that would make the donor ineligible, including relevant social behavior.
[66 FR 5466, Jan. 19, 2001, as amended at 71 FR 14798, Mar. 24, 2006]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.75.
- 21 CFR 1271.3How does FDA define important terms in this part?13 letters cite both
- 21 CFR 1271.60What quarantine and other requirements apply before the donor-eligibility determination is complete?13 letters cite both
- 21 CFR 1271.155Exemptions and alternatives12 letters cite both
- 21 CFR 1271.85What donor testing is required for different types of cells and tissues?12 letters cite both
- 21 CFR 1271.90Are there other exceptions and what labeling requirements apply?12 letters cite both
- 21 CFR 1271.47What procedures must I establish and maintain?11 letters cite both
- 21 CFR 1271.80What are the general requirements for donor testing?11 letters cite both
- 21 CFR 1271.45What requirements does this subpart contain?9 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 1271.75 that FDA posted most recently.
- BiologicsView R3 Medical Companiesumbilical cord derived products (ReBellaWJ, ReBellaXO, ReBellaXOL, ReBellaCB)IssuedAug 14, 2026PostedAug 25, 2026
- 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
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