b. General responsibilities of sponsors 21 CFR 812.40

The sponsor-investigator is responsible for:

1. Selecting qualified investigators and providing them with the information they need to conduct an investigation properly.
2. Ensuring proper monitoring of the investigation.
3. Ensuring that IRB review and approval are obtained.
4. Submitting an IDE application to the FDA.
5. Ensuring that any reviewing IRB, FDA, and participating investigators are promptly informed of significant new information about an investigation.