Section 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) 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