Investigational Device Studies and Exemptions (IDE)

Information for FDA-regulated clinical trials of Investigational Devices (IDE).

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.

Start Here

Q-Submission (Pre-IDE) Meetings with the FDA

Obtain advice from the FDA about your IDE study through written correspondence or a meeting.

Information on Pre-IDE Meetings

Prepare an IDE Application to the FDA

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.

IDE Application Development

Maintain the IDE

A Sponsor-Investigator has three types of reporting responsibilities: IDE Supplements, IDE Reports, and IDE Amendments.

Maintaining Your IDE