21 CFR 1271.6
21 CFR 1271.6 is the regulation in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.10, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a biologics letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
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 1271.6.
- 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?1 letter cites both
- 21 CFR 1271.15Are there any exceptions from the requirements of this part?1 letter cites 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?1 letter cites both
- 21 CFR 1271.3How does FDA define important terms in this part?1 letter cites both
- 21 CFR 1271.75How do I screen a donor?1 letter cites both
- 21 CFR 210.3Definitions1 letter cites both
- 21 CFR 211.100Written procedures; deviations1 letter cites both
- 21 CFR 211.113Control of microbiological contamination1 letter cites both
Latest letters citing it
The letter citing 21 CFR 1271.6 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.