Abbreviated IDE Requirements

FDA regulations for conducting clinical trials involving non-significant risk devices

Take the next stepDownload

Who?

This resource may be used by anyone at U-M.

When?

Available to download.

How much?

Free

What is this resource?

This document describes the FDA regulations specific for conducting a clinical trial with a non-significant risk (NSR) device.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research.

Translational Science Categories: