GUIDANCE FOR INDUSTRY
This guidance provides to you, medical device manufacturers of communicable disease tests, information about performing studies to support modifying the indication for use to include testing of cadaveric blood specimens to screen donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). This guidance makes recommendations about:
• Sensitivity and specificity studies • Reproducibility studies • Number of test kit lots to include in studies
• Plasma dilution issues
• Information about specimen collection times to be included
This document contains information which has been provided in Center for Biologic Evaluation and Research’s (CBER’s) letters to manufacturers of communicable disease tests. We, FDA, continue to encourage Manufacturers of communicable disease tests to evaluate these tests for cadaveric HCT/P donor use and seek such labeling.