The use of human subjects (or human specimens) is what determines the transition to IDE, and starts the process of having to determine the risks to the human subjects. If the ultimate goal of the device under investigation is to diagnose, cure, treat, mitigate, or prevent disease, then once any human subjects or human specimens are used, regardless of the phase of the study or the amount of data being collected, IDE regulations apply, unless the study is exempted from IDE regulations based on 21 CFR 812.2(c). Is the device subject to IDE regulations? The following steps summarize the IDE determination process: Step 1. FDA notifies the sponsor that an IDE application is required for an investigation.The sponsor or sponsor-investigator intends to conduct an investigation that involves an exception from informed consent under 21 CFR 50.24 or.The sponsor or sponsor-investigator intends to use a significant risk device in an investigation.Studies with devices can also be exempt from the IDE regulations under 21 CFR 812.2(c).Ī sponsor or sponsor-investigator is required to submit an IDE application to the FDA if:.Studies with non-significant risk (NSR) devices only need to follow abbreviated IDE regulations under 21 CFR 812.2 (b), and require only IRB approval before the start of the investigation.Studies with significant risk (SR) devices must follow all IDE regulations under 21 CFR 812, must have an FDA approved IDE application, and an IRB approval before the start of the investigation.Investigational devices covered under the IDE regulation are subject to different levels of regulations depending upon the level of risk (i.e., significant risk (SR) and non-significant risk (NSR) device studies). This regulation details procedures for the conduct of clinical studies with medical devices including applications, responsibilities of sponsors and investigators, labeling, records, and reports. IDE Regulatory RequirementsįDA 21 CFR 812 is the US federal regulation that covers IDEs. The federal regulations for IDEs are found at 21 CFR 812.Īll clinical investigations of medical devices require IRB review and approval. Please review our flowchart on the IDE process for more information. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. Investigational use of a device also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. Only a small percentage of 510(k)s require clinical data to support the application. Clinical studies are most often conducted to support a Food and Drug Administration (FDA) Premarket Application (PMA). Specific questions and inquiries regarding IDE Applications should be addressed to the FDA.Īn Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Information below is provided only as guidance. The following information is provided to guide sponsor-investigators (SI) through the Investigational Device Exemption (IDE) process.
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