Investigation
This is the 21 CFR 812 sense of the word. It sets the scope of the IDE rules.
Investigation means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device.
21 CFR, 812.3
This is the 21 CFR 812 sense of the word. It sets the scope of the IDE rules.
Investigation means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device.
21 CFR, 812.3