# 21 C.F.R. § 1271.10 (2026): 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?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_10

## Section

- **Citation:** 21 C.F.R. § 1271.10 (2026)
- **Heading:** 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?
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 1271: HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS / Subpart A: General Provisions / § 1271.10: § 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?

## Text

(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]

## Nearby sections

- [21 C.F.R. § 1271.1 (2026) § 1271.1   What are the purpose and scope of this part?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_1.md)
- [21 C.F.R. § 1271.3 (2026) § 1271.3   How does FDA define important terms in this part?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_3.md)
- [21 C.F.R. § 1271.10 (2026) § 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?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_10.md)
- [21 C.F.R. § 1271.15 (2026) § 1271.15   Are there any exceptions from the requirements of this part?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_15.md)
- [21 C.F.R. § 1271.20 (2026) § 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?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_20.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_10. Check the current official text before relying on it. Not legal advice.