Johns Hopkins Medicine1y
FDA 814.1 Organization Policy on Humanitarian Use Devices
The Organization allows use of Humanitarian Use Devices (HUD ... clinical data demonstrating "effectiveness'' (as defined under (21 CFR 860.7 (e)(1).) The FDA may grant HUD designation to a device ...
Johns Hopkins Medicine1y
103.19a Organization Policy on Drug Use and Control in Clinical Investigations
DUCI (Drug Used in a Clinical Investigation): Any drug, biological, botanical, or other substance used for a clinical investigation as named in the investigational protocol/IRB application and a dose, ...