21 CFR 1271.45
What requirements does this subpart contain?
21 CFR 1271.45 is the regulation titled “What requirements does this subpart contain?” 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 2 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.155, in 9 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 1271.45 most often, as written in the letters.
- 1 letterFailure of the summary of records, required under 1271.55(a)(3), to contain a listing and interpretation of the results of all communicable disease tests performed [21 CFR 1271.55(b)(2)]. For example, your *SUMMARY…
- 1 letterFailure 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…
- 1 letterFailure to establish and maintain procedures for all steps performed in testing, screening, determining donor eligibility, and complying with all other requirements of Subpart C “Donor Eligibility” in 21 CFR Part…
The regulation
Read the text of 21 CFR 1271.45 (eCFR, as of Sep 1, 2026)
(a) General. This subpart sets out requirements for determining donor eligibility, including donor screening and testing. The requirements contained in this subpart are a component of current good tissue practice (CGTP) requirements. Other CGTP requirements are set out in subpart D of this part.
(b) Donor-eligibility determination required. A donor-eligibility determination, based on donor screening and testing for relevant communicable disease agents and diseases, is required for all donors of cells or tissue used in HCT/Ps, except as provided under § 1271.90. In the case of an embryo or of cells derived from an embryo, a donor-eligibility determination is required for both the oocyte donor and the semen donor.
(c) Prohibition on use. An HCT/P must not be implanted, transplanted, infused, or transferred until the donor has been determined to be eligible, except as provided under §§ 1271.60(d), 1271.65(b), and 1271.90 of this subpart.
(d) Applicability of requirements. If you are an establishment that performs any function described in this subpart, you must comply with the requirements contained in this subpart that are applicable to that function.
[69 FR 29830, May 25, 2004, as amended at 69 FR 68681, Nov. 24, 2004]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.45.
- 21 CFR 1271.155Exemptions and alternatives9 letters cite both
- 21 CFR 1271.47What procedures must I establish and maintain?9 letters cite both
- 21 CFR 1271.60What quarantine and other requirements apply before the donor-eligibility determination is complete?9 letters cite both
- 21 CFR 1271.75How do I screen a donor?9 letters cite both
- 21 CFR 1271.90Are there other exceptions and what labeling requirements apply?9 letters cite both
- 21 CFR 1271.85What donor testing is required for different types of cells and tissues?8 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?7 letters cite both
- 21 CFR 1271.80What are the general requirements for donor testing?7 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 1271.45 that FDA posted most recently.
- 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
- BiologicsView InVia Fertility Specialists, PLLCReproductive cells and tissues (oocytes, semen, embryos)IssuedJun 13, 2025PostedJul 1, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.