FDA 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