An Investigational Device Exemption (IDE) allows an 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 Food and Drug Administration (FDA).
A significant risk device poses a “potential for serious risk to the health, safety, or welfare of a subject.” Significant risk devices may include:
Such devices may only be studied under an IDE granted by the FDA.
A sponsor of a significant risk device study must submit a complete IDE application to FDA. There are no preprinted forms for an IDE application; however, an IDE application must include certain required information. The sponsor must demonstrate in the application that:
The following information must be included in an IDE application for a significant risk device investigation:
Due to the amount and complexity of the data required for an IDE application, it can take several weeks to complete an IND submission. Therefore, we recommend you begin working on an IDE submission as early as possible.
If the use of the investigational device will take place in any of the Kaleida Health facilities (angiography suite, operating room, emergency department, clinic), the device MUST be built into Kaleida’s Lawson system for tracking and billing purposes regardless of who is supplying/paying for the device. The Clinical Research Office will facilitate the completion of the Product List Template for submittal to Kaleida’s Office of Research and Sponsored Projects.
If use of the investigational device will take place at ECMC, the Clinical Research Application must be completed, reviewed and approved by ECMC’s Office of Clinical Research Coordination.
The worksheet used by IRB reviewers to assess your IDE application is in the Click portal—IRB library section under the “Worksheets” tab. It is called “HRP-307-Worksheet-Device.” Reading this worksheet may help you understand the criteria and level of detail that the IRB and/or FDA need to make a determination.
Please find additional detail below: