FDA 312/812 Organization Policy on Clinical Investigations with FDA “Test Articles”

August 2010

The Organization authorizes the JHM IRB to review studies involving FDA regulated “test articles.”  Test articles may include drugs, botanicals, biologics, gene therapy, genetically derived products, and medical devices, as defined under FDA regulations on protection of human subjects (21 CFR 50 and 21 CFR 56), and the Investigational New Drug (IND) and Investigational Device Exemption (IDE) regulations (21 CFR 312 and 21 CFR 812).