§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?
21 C.F.R. § 1271.10
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:
The HCT/P is minimally manipulated;
The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;
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
Either—
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
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.
If you are a domestic or foreign establishment that manufactures an HCT/P described in paragraph (a) of this section:
You must register with FDA;
You must submit to FDA a list of each HCT/P manufactured; and
You must comply with the other requirements contained in this part.
Notes, amendments, and revision history
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]