Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff." The guidance provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff, with FDA's current thinking on the regulatory criteria of minimal manipulation and homologous use. The guidance is intended to improve stakeholders' understanding of the definitions of minimal manipulation and homologous use and how the regulatory criteria apply to their HCT/Ps. It also informs manufacturers, healthcare providers, and other interested persons that the Agency generally intends to exercise enforcement discretion over the next 36 months under limited conditions, with respect to the investigational new drug (IND) application and premarket approval (biologics license application (BLA)) requirements, for certain HCT/Ps.