21 CFR §1271.10

1. (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. (1)The HCT/P is minimally manipulated;
   2. (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. (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. (4)Either:
      1. (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
      2. (ii)The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
         1. (a)Is for autologous use;
         2. (b)Is for allogeneic use in a first-degree or second-degree blood relative; or
         3. (c)Is for reproductive use.
2. (b)If you are a domestic or foreign establishment that manufactures an HCT/P described in paragraph (a) of this section:
   1. (1)You must register with FDA;
   2. (2)You must submit to FDA a list of each HCT/P manufactured; and
   3. (3)You must comply with the other requirements contained in this part.