IDE Overview
UCSF investigators who will initiate their own research protocol to study a device and do not have an industry sponsor should begin here.
Information for FDA-regulated clinical trials of Investigational Devices (IDE).
UCSF investigators who will initiate their own research protocol to study a device and do not have an industry sponsor should begin here.
Obtain advice from the FDA about your IDE study through written correspondence or a meeting.
Investigators proposing clinical trials that are not IDE exempt or Non-Significant Risk (see Overview) should follow these steps to prepare an IDE application to FDA.
A Sponsor-Investigator has three types of reporting responsibilities: IDE Supplements, IDE Reports, and IDE Amendments.
Links to the IDE resources referenced on all other pages.