Originally Published MDDI January 2004
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An IDE is required for devices that pose a significant risk to patients participating in a clinical trial. IDE approval allows a company that would otherwise be subject to premarket approval to ship the device for the purpose of conducting a clinical trial.
In order to be considered for an IDE, a company has to file an IDE application with FDA. Among other requirements, the application needs to include information on the nature and design of the device, risk analysis, patient safety, manufacturing, and monitoring; clinical protocol and consent forms; and lists of investigators and institutions.5
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