# 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?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.10

## Section

- **Citation:** 21 CFR § 1271.10
- **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:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION > PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS > Subpart A—General Provisions

## 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 CFR § 1271.1 § 1271.1 What are the purpose and scope of this part?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.1.md)
- [21 CFR § 1271.3 § 1271.3 How does FDA define important terms in this part?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.3.md)
- [21 CFR § 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?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.10.md)
- [21 CFR § 1271.15 § 1271.15 Are there any exceptions from the requirements of this part?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.15.md)
- [21 CFR § 1271.20 § 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/ecfr-21-1271.20.md)
- [21 CFR § 1271.21 § 1271.21 When do I register, submit an HCT/P list, and submit updates?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.21.md)
- [21 CFR § 1271.22 § 1271.22 How do I register and submit an HCT/P list?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.22.md)
- [21 CFR § 1271.23 § 1271.23 How is a waiver from the electronic format requirements requested?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.23.md)
- [21 CFR § 1271.25 § 1271.25 What information is required for establishment registration and HCT/P listing?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.25.md)
- [21 CFR § 1271.26 § 1271.26 When must I amend my establishment registration?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.26.md)
- [21 CFR § 1271.27 § 1271.27 Will FDA assign me a registration number?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.27.md)
- [21 CFR § 1271.37 § 1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.37.md)
- [21 CFR § 1271.45 § 1271.45 What requirements does this subpart contain?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.45.md)
- [21 CFR § 1271.47 § 1271.47 What procedures must I establish and maintain?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.47.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.10. Check the current official text before relying on it. Not legal advice.