21 CFR 1271.15
Are there any exceptions from the requirements of this part?
21 CFR 1271.15 is the regulation titled “Are there any exceptions from the requirements of this part?” 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 1271.10, 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 1271.15 most often, as written in the letters.
- 1 letterFor example, you do not qualify for the exception in 21 CFR 1271.15(b), which provides that an “establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same…
- 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 1271.15 (eCFR, as of Sep 1, 2026)
(a) You are not required to comply with the requirements of this part if you are an establishment that uses HCT/P's solely for nonclinical scientific or educational purposes.
(b) You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure.
(c) You are not required to comply with the requirements of this part if you are a carrier who accepts, receives, carries, or delivers HCT/P's in the usual course of business as a carrier.
(d) You are not required to comply with the requirements of this part if you are an establishment that does not recover, screen, test, process, label, package, or distribute, but only receives or stores HCT/P's solely for implantation, transplantation, infusion, or transfer within your facility.
(e) You are not required to comply with the requirements of this part if you are an establishment that only recovers reproductive cells or tissue and immediately transfers them into a sexually intimate partner of the cell or tissue donor.
(f) You are not required to register or list your HCT/P's independently, but you must comply with all other applicable requirements in this part, if you are an individual under contract, agreement, or other arrangement with a registered establishment and engaged solely in recovering cells or tissues and sending the recovered cells or tissues to the registered establishment.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.15.
- 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?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 1271.15 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.