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Investigational Device Exemption Applications (IDEs)

An investigational device exemption (IDE) application allows a sponsor to use an uncleared or unapproved medical device in a clinical study to collect safety and effectiveness data to support a 510(k) or PMA submission to the FDA. Sponsors must obtain IDE approval before the study begins. The IDE application must be approved by an institutional review board (IRB), and if the device is a "significant risk device", it must also be approved by the FDA. In addition, the sponsor must ensure that all patients in the study provide informed consent, the device under evaluation must be labeled "for investigational use only", the study must be monitored appropriately, and the sponsor must prepare certain required records and reports. An approved IDE allows the device to be shipped lawfully for use in the study without complying with other FDA requirements that would apply to devices in commercial distribution.

IDE Application Assistance

MDCI will work with you to write, edit and organize your IDE application for presentation to the FDA. Typically, an IDE application includes the following: a detailed description of the device and an explanation of how it works, final reports of prior studies performed on the device, the Investigational Plan (including the protocol, case report forms, informed consent form, investigator agreement, risk analysis, statistical plan, and monitoring procedures), labeling and device labels appropriate for the clinical study, and a summary of manufacturing procedures.

If you have not had previous contact with the FDA or if you are proposing to study new technologies or new uses for existing technologies, MDCI can also provide assistance with pre-IDE activities.

Contact MDCI today to see how we can help with your IDE Application.

Learn More About MDCI's Assistance with Other FDA Submissions Including:

• 510(k) Premarket Notifications
• Premarket Approval Applications (PMAs)
• Investigational New Drug Applications (INDs)
• 513(g) Requests for Classification