21 CFR 1271.2
21 CFR 1271.2 is the regulation in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 7 FDA warning letters have cited it.
- Letters citing it
- 7 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.10, in 7 letters
- Closed out
- 0% 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
The text of this section is not in the saved copy.
Text from eCFR.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.2.
- 21 CFR 1271.10Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?7 letters cite both
- 21 CFR 1271.15Are there any exceptions from the requirements of this part?7 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?7 letters cite both
- 21 CFR 1271.20If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?5 letters cite both
- 21 CFR 211.100Written procedures; deviations2 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use1 letter cites both
- 21 CFR 211.113Control of microbiological contamination1 letter cites both
- 21 CFR 211.160General requirements1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 1271.2 that FDA posted most recently.
- BiologicsView Calibrate IV HydrationUmbilical cord derived and exosome products for allogeneic useIssuedOct 13, 2026PostedOct 27, 2026
- BiologicsView Blue Horizon International, LLCumbilical cord blood derived stem cell product and WJ-MSC/UC exosome productIssuedMay 26, 2026PostedJun 2, 2026
- BiologicsView Microvascular Tissue, Inc.mVASCIssuedDec 3, 2025PostedDec 16, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.