Investigational Devices: Will the study involve Investigational Devices?
WHY THIS INFORMATION IS IMPORTANT TO THE IRB:
Information about investigational devices is important to the DOH IRB in assessing the risk/benefit ratio of the study.
INVESTIGATOR HELP:
If you are using a device, upload the following below in Section VI of the application.
Commercial Sponsor Protocol imprinted with the IDE number.
Letter from sponsor documenting the IDE number
Letter from FDA documenting the IDE number of the protocol.