IDE Overview and Starting Point

Only clinical investigations of medical devices require compliance with Investigational Device Exemption (IDE) requirements (21 CFR 812). 

A clinical investigation of a medical device is a clinical study designed to evaluate the effectiveness and/or safety of the medical device.

A medical device is defined as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized and is either:

1. Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, OR
2. Intended to affect the structure or function of the body, OR
3. Recognized as a medical device in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them.

Common pitfalls:

1. If you are using a medical device (regardless of whether it is FDA approved or investigational) in your study but are not evaluating the safety and/or effectiveness of that device as one of the study aims, your study does not qualify as a clinical investigation of a medical device under FDA regulations.
2.  Certain studies using in vitro diagnostic (IVD) devices (for example, in precision/personalized medicine studies) may still qualify as a clinical investigation of a device even if evaluating the safety and/or effectiveness of the IVD are not part of the study aims under current FDA guidance external site (opens in a new window) (Dec 2017).

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 external site (opens in a new window) .

Q-Submissions can increase the likelihood of a successful IDE application, shorten FDA review time, or help investigators address inquiries regarding the applicability of IDE regulations to their research.

The IDE Responsibilities Checklist is intended to prepare UCSF sponsor-investigators for studies conducted under an IDE.

Please refer to the following sample SOPs for clinical investigations:

• Sample SOPs adapted from Emory University 
• Duke University Sample Clinical Trial SOPs external site (opens in a new window)

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.