Guide on HCT/P Minimal Manipulation and Homologous Use

Federal Register notice: FDA has made available a guidance entitled “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.” The document provides the agency’s current thinking on the regulatory criteria of minimal manipulation and homologous use. It 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 IND application and BLA requirements, for certain HCT/Ps. To view the notice, click here.