We, FDA, are providing you, human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff, with our current thinking on the criteria under Title 21 of the Code of Federal Regulations (CFR) Part 1271, specifically the 21 CFR 1271.10(a)(1) criterion of minimal manipulation and the 21 CFR 1271.10(a)(2) criterion of homologous use. The interpretation of the minimal manipulation and homologous use criteria and definitions of related key terms have been of considerable interest to industry stakeholders since the criteria and definitions were first proposed. This guidance is intended to improve stakeholders’ understanding of the definitions of minimal manipulation in 21 CFR 1271.3(f) and homologous use in 21 CFR 1271.3(c). It will also facilitate stakeholders’ understanding of how the regulatory criteria in 21 CFR 1271.10(a)(1) and (2) apply to their HCT/Ps. In addition, we are informing manufacturers, healthcare providers, and other interested persons that over the next 36 months, we intend to exercise enforcement discretion under limited conditions with respect to the investigational new drug (IND) application and premarket approval (biologics license application (BLA)) requirements, for certain HCT/Ps.
This guidance finalizes the document entitled “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry and Food Administration Staff” dated December 2014, and “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry and FDA Staff” dated October 2015. This guidance also finalizes certain material related to adipose tissue that was included in draft guidance entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry” dated December 2014 (Adipose Draft Guidance). This material, together with the material related to adipose tissue included in the final guidance entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b); Questions and Answers Regarding the Scope of the Exception” dated November 2017, supersedes the Adipose Draft Guidance. Accordingly, we do not intend to finalize the Adipose Draft Guidance, which is now withdrawn. Finally, this guidance supersedes the document entitled “Minimal Manipulation of Structural Tissue (Jurisdictional Update); Guidance for Industry and FDA Staff” dated September 2006 (2006 Guidance).