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September 12, 2023

Who Is Responsible For Making the Initial Risk Determination For a Device Being Used in a Clinical Study?

If you want to get your medical device on the market, you have to be careful what you say about its intended use and indications of use. There is more strategy and thought that goes into those statements than many people think. Our guest today, Mike Drues, is a leading expert in this area and travels the globe helping set companies and regulatory bodies like FDA straight on how to design great intended use and indications of use statements.

Research involving unapproved devices on human participants is only legal when performed under an Investigational Device Exemption (IDE). All clinical studies involving a significant risk (SR) device must be approved by both the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) and by WSU’s IRB prior to the onset of the study.

In addition, if the device is being used for treatment use in a disease state that is not immediately life-threatening, the manufacturer may apply to the Secretary of Health and Human Services for an exemption from the IDE requirements. The application must include a description of the device and reports of prior investigations of the device, a risk analysis, a proposed investigator and a clinical trial plan.

For all other clinical studies involving nonsignificant risk (NSR) devices, the sponsor and/or principal investigator is responsible for making the initial determination that the study does not pose an unreasonable risk to the participants. The determination must be documented in the IRB Committee minutes with justification for the decision.