21 CFR 1271.10
Are 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?
21 CFR 1271.10 is the regulation titled “Are 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?” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 36 FDA warning letters have cited it.
- Letters citing it
- 36 since 2021
- Jan 1 to Oct 30, 2026
- 6 against 6 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.15, in 36 letters
- Closed out
- 8% 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 1271.10 most often, as written in the letters.
- 1 letterEVO HYBRID™ fails to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1) because the umbilical cord and amniotic membrane undergo processing…
- 1 letterFurthermore, your SVF product fails to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1). Adipose tissue is typically defined as a…
- 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…
The regulation
Read the text of 21 CFR 1271.10 (eCFR, as of Sep 1, 2026)
(a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:
(1) The HCT/P is minimally manipulated;
(2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;
(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
(4) Either:
(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
(a) Is for autologous use;
(b) Is for allogeneic use in a first-degree or second-degree blood relative; or
(c) Is for reproductive use.
(b) If you are a domestic or foreign establishment that manufactures an HCT/P described in paragraph (a) of this section:
(1) You must register with FDA;
(2) You must submit to FDA a list of each HCT/P manufactured; and
(3) You must comply with the other requirements contained in this part.
[66 FR 5466, Jan. 19, 2001, 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 1271.10.
- 21 CFR 1271.15Are there any exceptions from the requirements of this part?36 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?36 letters cite both
- 21 CFR 211.100Written procedures; deviations22 letters cite both
- 21 CFR 211.113Control of microbiological contamination18 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?17 letters cite both
- 21 CFR 211.160General requirements16 letters cite both
- 21 CFR 211.166Stability testing16 letters cite both
- 21 CFR 211.42Design and construction features16 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 1271.10 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.