IDE Overview

Confused about the need to file an IDE? Think your study may be exempt? Not sure where to start? You are not alone. This website will help faculty navigate the process of developing a Sponsor-Investigator IDE. The information provided pertains to Class III and some Class II devices, that is, devices with the greatest risk or those that have a new intended use or employ a new, unique technology.  

The sponsor of a Significant Risk (SR) device study is required to submit an IDE application to the FDA.  The IDE allows the investigational device to be used in a clinical study in order to collect the safety and effectiveness data required to support a marketing application.

Use the Investigator Checklist for IDE Exempt, Non-Significant Risk,or Significant Risk Device Studies to help you determine if an IDE is required.  While the first step is a self-assesement of whether an IDE is needed, the IRB serves as a first-level review as designated by FDA.  FDA makes the ultimate decision, if needed.

Need assistance or have regulatory questions? Please contact CTSI Consultation Services

New:

The FDA has issued guidance on “Mobile Medical Applications” to clarify the subset of mobile apps to which the FDA intends to apply its authority. Guidance is also now available for "‘Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies."  

On June 20, 2014 the FDA issued draft guidance regarding Medical Device Data Systems (MDDS), Medical Image Storage Devices, and Medical Image Communication Devices. The draft guidance also contains some edits to the 2013 Mobile Medical Applications Guidance to conform to its draft guidance here.

eCopy Program for Medical Device Submissions