---
kind: "section"
citation: "21 C.F.R. § 1271.10"
title: "21"
number: "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?"
url: "https://uscodex.org/cfr/21/1271.10"
---

# §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?

- (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)](#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.

## Notes

### Amendments

[66 FR 5466, Jan. 19, 2001, as amended at 69 FR 68681, Nov. 24, 2004]

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.

### Amendments

[66 FR 5466, Jan. 19, 2001, as amended at 69 FR 68681, Nov. 24, 2004]