RESOURCES

Significant Risk Studies (SR)

If a study is Significant Risk (SR) then an Investigational Device Exemption (IDE) approval must be obtained from the FDA.

Non-Significant Risk Studies (NSR)

If a study is determined to be non-significant risk (NSR) the abbreviated IDE rules apply.

Investigational Device Exemption (IDE)

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.

FDA: Medical Devices

US Food and Drug Administration Medical Devices Homepage

FDA IRB (Investigational Review Boards)

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects.