21 CFR 1271.85
What donor testing is required for different types of cells and tissues?
21 CFR 1271.85 is the regulation titled “What donor testing is required for different types of cells and tissues?” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 12 FDA warning letters have cited it.
- Letters citing it
- 12 since 2021
- Jan 1 to Oct 30, 2026
- 3 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.60, in 12 letters
- Closed out
- 8% 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 1271.85 most often, as written in the letters.
- 2 lettersFailure to test a specimen from an anonymous or directed reproductive donor of cells or tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents [21 CFR 1271.85(a)].…
- 1 letterFailure to determine as ineligible a donor whose specimen tests reactive on a screening test for a communicable disease agent for which testing is required under 21 CFR 1271.85 [21 CFR 1271.80(d)(1)]. For example, a…
- 1 letterFailure to determine whether a donor is eligible based upon the results of donor screening in accordance with 21 CFR 1271.75 and donor testing in accordance with 21 CFR 1271.80 and 21 CFR 1271.85 [21 CFR 1271.50(a)].…
The regulation
Read the text of 21 CFR 1271.85 (eCFR, as of Sep 1, 2026)
(a) All donors. To adequately and appropriately reduce the risk of transmission of relevant communicable diseases, and except as provided under § 1271.90, you must test a specimen from the donor of cells or tissue, whether viable or nonviable, for evidence of infection due to relevant communicable disease agents, including:
(1) Human immunodeficiency virus, type 1;
(2) Human immunodeficiency virus, type 2;
(3) Hepatitis B virus;
(4) Hepatitis C virus; and
(5) Treponema pallidum.
(b) Donors of viable, leukocyte-rich cells or tissue. In addition to the relevant communicable disease agents for which testing is required under paragraph (a) of this section, and except as provided under § 1271.90,
(1) You must test a specimen from the donor of viable, leukocyte-rich cells or tissue to adequately and appropriately reduce the risk of transmission of relevant cell-associated communicable diseases, including:
(i) Human T-lymphotropic virus, type I; and
(ii) Human T-lymphotropic virus, type II.
(2) You must test a specimen from the donor of viable, leukocyte-rich cells or tissue for evidence of infection due to cytomegalovirus (CMV), to adequately and appropriately reduce the risk of transmission. You must establish and maintain a standard operating procedure governing the release of an HCT/P from a donor whose specimen tests reactive for CMV.
(c) Donors of reproductive cells or tissue. In addition to the communicable disease agents for which testing is required under paragraphs (a) and (b) of this section, as applicable, and except as provided under § 1271.90, you must test a specimen from the donor of reproductive cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract. Such testing must include testing 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 testing 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 test include:
(1) Chlamydia trachomatis; and
(2) Neisseria gonorrhea.
(d) Retesting anonymous semen donors. Except as provided under § 1271.90 and except for directed reproductive donors as defined in § 1271.3(l), at least 6 months after the date of donation of semen from anonymous donors, you must collect a new specimen from the donor and test it for evidence of infection due to the communicable disease agents for which testing is required under paragraphs (a), (b), and (c) of this section.
(e) Dura mater. For donors of dura mater, you must perform an adequate assessment designed to detect evidence of transmissible spongiform encephalopathy.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.85.
- 21 CFR 1271.60What quarantine and other requirements apply before the donor-eligibility determination is complete?12 letters cite both
- 21 CFR 1271.75How do I screen a donor?12 letters cite both
- 21 CFR 1271.155Exemptions and alternatives11 letters cite both
- 21 CFR 1271.90Are there other exceptions and what labeling requirements apply?11 letters cite both
- 21 CFR 1271.80What are the general requirements for donor testing?10 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?9 letters cite both
- 21 CFR 1271.45What requirements does this subpart contain?8 letters cite both
- 21 CFR 1271.47What procedures must I establish and maintain?8 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 1271.85 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 Louisville Reproductive Centerreproductive cells and tissue (semen, oocytes, embryos)IssuedJan 23, 2026PostedFeb 10, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.