HUMAN CELLS AND TISSUE PRODUCTS (HCT\/P) REGULATIONS<\/p>\n
According to FDA 21 CFR 1271, 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:<\/p>\n
(1) The HCT\/P is minimally manipulated;<\/p>\n
(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;<\/p>\n
(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<\/p>\n
(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.<\/p>\n
To learn more about FDA Regulations, please visit the following link: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=1271<\/a><\/p>\n <\/p>\n More: <\/p>\n What is Stem Cell Therapy?<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" HUMAN CELLS AND TISSUE PRODUCTS (HCT\/P) REGULATIONS According to FDA 21 CFR 1271, 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. To learn more about FDA Regulations, please visit the following link: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=1271<\/a> Continue reading