Overview
Before initiating a clinical investigation to study a device (including an in vitro diagnostic device or mobile medical application), review these steps to determine how to comply with Food and Drug Administration (FDA) requirements. This page is intended for UCSF investigators who will initiate their own research protocol and do not have an industry sponsor.
Step1
Explore whether your study may be exempt fro the IDE requirement or is Non-Significant Risk.
Before submitting an IDE application to FDA, determine whether your clinical trial meets the regulatory criteria for exemption from the IDE requirement, or if it is considered a Non-Significant Risk (NSR) device as used in the proposed research.
Unsure? The UCSF Regulatory Support team can help you determine whether the IRB is likely to agree that your study is IDE exempt or NSR. Request a consult.
Is your study IDE exempt or NSR?Step2
Consider a Q-Submission (Pre-IDE) meeting with the FDA.
Q-Submissions can increase the likelihood of a successful IDE application, shorten FDA review time, or help investigators address FDA safety concerns with an IDE application.
Review the Q-Submission ProcessStep3
Submit an IDE application to FDA (if required).
If a planned clinical trial of a device does not qualify for IDE exemption, and the IRB or FDA does not believe the use of the device is Non-Significant Risk (NSR), the investigator should follow the steps below to prepare an IDE application for submission to FDA.
Submitting Your Initial IDE