21 CFR 1271.47
What procedures must I establish and maintain?
21 CFR 1271.47 is the regulation titled “What procedures must I establish and maintain?” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 11 FDA warning letters have cited it.
- Letters citing it
- 11 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.75, in 11 letters
- Closed out
- 18% 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 1271.47 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 1271.47 (eCFR, as of Sep 1, 2026)
(a) General. You must establish and maintain procedures for all steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements of this subpart. Establish and maintain means define, document (in writing or electronically), and implement; then follow, review, and as needed, revise on an ongoing basis. You must design these procedures to ensure compliance with the requirements of this subpart.
(b) Review and approval. Before implementation, a responsible person must review and approve all procedures.
(c) Availability. Procedures must be readily available to the personnel in the area where the operations to which they relate are performed, or in a nearby area if such availability is impractical.
(d) Departures from procedures. You must record and justify any departure from a procedure relevant to preventing risks of communicable disease transmission at the time of its occurrence. You must not make available for distribution any HCT/P from a donor whose eligibility is determined under such a departure unless a responsible person has determined that the departure does not increase the risks of communicable disease transmission through the use of the HCT/P.
(e) Standard procedures. You may adopt current standard procedures, such as those in a technical manual prepared by another organization, provided that you have verified that the procedures are consistent with and at least as stringent as the requirements of this part and appropriate for your operations.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.47.
- 21 CFR 1271.75How do I screen a donor?11 letters cite both
- 21 CFR 1271.155Exemptions and alternatives9 letters cite both
- 21 CFR 1271.45What requirements does this subpart contain?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 1271.90Are 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 1271.47 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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