21 CFR 1271.20
If 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?
21 CFR 1271.20 is the regulation titled “If 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?” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 17 FDA warning letters have cited it.
- Letters citing it
- 17 since 2021
- Jan 1 to Oct 30, 2026
- 6 against 6 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.10, in 17 letters
- Closed out
- 6% 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 1271.20 most often, as written in the letters.
- 1 letterOn your website, https://innatehealthcare.org, you provide the following statements: - "At Innate Healthcare Institute, we combine an effective blend of integrative medicine and regenerative stem cell medicine, treating…
- 1 letteryour products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your products are also unlicensed biological products in violation of…
The regulation
Read the text of 21 CFR 1271.20 (eCFR, as of Sep 1, 2026)
If you are an establishment that manufactures an HCT/P that does not meet the criteria set out in § 1271.10(a), and you do not qualify for any of the exceptions in § 1271.15, your HCT/P will be regulated as a drug, device, and/or biological product under the act and/or section 351 of the PHS Act, and applicable regulations in title 21, chapter I. Applicable regulations include, but are not limited to, §§ 207.9(a)(5), 210.1(c), 210.2, 211.1(b), 807.20(d), and 820.1(a) of this chapter, which require you to follow the procedures in subparts C and D of this part.
[66 FR 5466, Jan. 19, 2001, as amended at 81 FR 60223, Aug. 31, 2016]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.20.
- 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?17 letters cite both
- 21 CFR 1271.15Are there any exceptions from the requirements of this part?17 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?17 letters cite both
- 21 CFR 211.100Written procedures; deviations7 letters cite both
- 21 CFR 1271.1What are the purpose and scope of this part?6 letters cite both
- 21 CFR 1271.25 letters cite both
- 21 CFR 211.113Control of microbiological contamination5 letters cite both
- 21 CFR 211.160General requirements5 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 1271.20 that FDA posted most recently.
- BiologicsView Calibrate IV HydrationUmbilical cord derived and exosome products for allogeneic useIssuedOct 13, 2026PostedOct 27, 2026
- BiologicsView Beaute Bountyembryonic stem cell and placenta-derived products (Evgenis Totipotent Embryonic Stem Cells, Laennec, Melsmon Placenta Japan)IssuedSep 25, 2026PostedOct 27, 2026
- BiologicsView NexCell Scientific Incumbilical cord blood-derived total nucleated cell (TNC) productIssuedSep 11, 2026PostedSep 22, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.