Guidance for Industry and Food and Drug Administration Staff Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products

The Parenteral Drug Association (PDA) commends FDA for addressing and characterizing the important concepts of minimal manipulation and related terms for HCT/P products. These concepts are difficult and undoubtedly will continue to be challenged as new, innovative tools are introduced to process cellular and tissue-based products. The format of questions followed by discussion in this guidance makes it easy to find information and follow the logic of the applicable regulation. Such guidance, with a very directed and limited scope, are a helpful means to communicate FDAs latest thinking in a timely and efficient manner. See also the attached file.