21 CFR 1271.90
Are there other exceptions and what labeling requirements apply?
21 CFR 1271.90 is the regulation titled “Are there other exceptions and what labeling requirements apply?” 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 1271.155, 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.
The regulation
Read the text of 21 CFR 1271.90 (eCFR, as of Sep 1, 2026)
(a) Donor-eligibility determination not required. You are not required to make a donor-eligibility determination under § 1271.50 or to perform donor screening or testing under §§ 1271.75, 1271.80 and 1271.85 for:
(1) Cells and tissues for autologous use; or
(2) Reproductive cells or tissue donated by a sexually intimate partner of the recipient for reproductive use; or
(3) Cryopreserved cells or tissue for reproductive use, other than embryos, originally excepted under paragraphs (a)(1) or (a)(2) of this section at the time of donation, that are subsequently intended for directed donation, provided that:
(i) Additional donations are unavailable, for example, due to the infertility or health of a donor of the cryopreserved reproductive cells or tissue; and
(ii) Appropriate measures are taken to screen and test the donor(s) before transfer to the recipient.
(4) A cryopreserved embryo, originally excepted under paragraph (a)(2) of this section at the time of recovery or cryopreservation, that is subsequently intended for directed or anonymous donation. When possible, appropriate measures should be taken to screen and test the semen and oocyte donors before transfer of the embryo to the recipient.
(b) Exceptions for reproductive use. An embryo originally intended for reproductive use for a specific individual or couple that is subsequently intended for directed or anonymous donation for reproductive use is excepted from the prohibition on use under § 1271.45(c) even when the applicable donor eligibility requirements under subpart C of this part are not met. Nothing in this paragraph creates an exception for deficiencies that occurred in making the donor eligibility determination for either the oocyte donor or the semen donor as required under § 1271.45(b), or for deficiencies in performing donor screening or testing, as required under §§ 1271.75, 1271.80, and 1271.85.
(c) Required labeling. As applicable, you must prominently label an HCT/P described in paragraphs (a) and (b) of this section as follows:
(1) “FOR AUTOLOGOUS USE ONLY,” if it is stored for autologous use.
(2) “NOT EVALUATED FOR INFECTIOUS SUBSTANCES,” unless you have performed all otherwise applicable screening and testing under §§ 1271.75, 1271.80, and 1271.85. This paragraph does not apply to reproductive cells or tissue labeled in accordance with paragraph (c)(6) of this section.
(3) Unless the HCT/P is for autologous use only, “WARNING: Advise recipient of communicable disease risks,”
(i) When the donor-eligibility determination under § 1271.50(a) is not performed or is not completed; or
(ii) If the results of any screening or testing performed indicate:
(A) The presence of relevant communicable disease agents and/or
(B) Risk factors for or clinical evidence of relevant communicable disease agents or diseases.
(4) With the Biohazard legend shown in § 1271.3(h), if the results of any screening or testing performed indicate:
(i) The presence of relevant communicable disease agents and/or
(ii) Risk factors for or clinical evidence of relevant communicable disease agents or diseases.
(5) “WARNING: Reactive test results for (name of disease agent or disease),” in the case of reactive test results.
(6) “Advise recipient that screening and testing of the donor(s) were not performed at the time of recovery or cryopreservation of the reproductive cells or tissue, but have been performed subsequently,” for paragraphs (a)(3) or (a)(4) of this section.
[69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005; 81 FR 40517, June 22, 2016]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.90.
- 21 CFR 1271.155Exemptions and alternatives12 letters cite both
- 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 1271.85What donor testing is required for different types of cells and tissues?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?9 letters cite both
- 21 CFR 1271.47What procedures must I establish and maintain?9 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 1271.90 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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