21 CFR 1271.1
What are the purpose and scope of this part?
21 CFR 1271.1 is the regulation titled “What are the purpose and scope of this part?” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 6 FDA warning letters have cited it.
- Letters citing it
- 6 since 2021
- Jan 1 to Oct 30, 2026
- 3 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.10, in 6 letters
- Closed out
- 17% 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
Read the text of 21 CFR 1271.1 (eCFR, as of Sep 1, 2026)
(a) Purpose. The purpose of this part, in conjunction with §§ 207.9(a)(5), 210.1(c), 210.2, 807.20(d), and 820.1(a) of this chapter, is to create an electronic registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P's) and to establish donor-eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P's.
(b) Scope. (1) If you are an establishment that manufactures HCT/P's that are regulated solely under the authority of section 361 of the Public Health Service Act (the PHS Act), this part requires you to register and list your HCT/P's with the Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research and to comply with the other requirements contained in this part, whether or not the HCT/P enters into interstate commerce. Those HCT/P's that are regulated solely under the authority of section 361 of the PHS Act are described in § 1271.10.
(2) If you are an establishment that manufactures HCT/P's that are regulated as drugs, devices and/or biological products under section 351 of the PHS Act and/or the Federal Food, Drug, and Cosmetic Act, §§ 207.9(a)(5) and 807.20(d) of this chapter require you to register and list your HCT/P's following the procedures in part 207 (if a drug and/or biological product) of this chapter or part 807 (if a device) of this chapter. Sections 210.1(c), 210.2, 211.1(b), and 820.1(a) of this chapter require you to comply with the donor-eligibility procedures in subpart C of this part and the current good tissue practice procedures in subpart D of this part, in addition to all other applicable regulations.
[66 FR 5466, Jan. 19, 2001, as amended at 69 FR 29829, May 25, 2004; 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 1271.1.
- 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?6 letters cite both
- 21 CFR 1271.15Are there any exceptions from the requirements of this part?6 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?6 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?6 letters cite both
- 21 CFR 201.5Drugs; adequate directions for use2 letters cite both
- 21 CFR 211.100Written procedures; deviations2 letters cite both
- 21 CFR 211.113Control of microbiological contamination2 letters cite both
- 21 CFR 211.160General requirements2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 1271.1 that FDA posted most recently.
- 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
- BiologicsView Dynamic Stem Cell Therapyumbilical cord-derived stem cell productIssuedFeb 11, 2026PostedFeb 24, 2026
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.