• Investigational Device Exemption (IDE) – 21CFR Part 812
• IDE content
• Institutional Review Board (IRB)
22.6.1 An Investigational Device Exemption Overview
An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a PMA application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
Clinical trials using unapproved medical devices on human subjects are performed under an Investigational Device Exemption (IDE). Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB) prior to initiation of a clinical study. An FDA approval is obtained by submitting an IDE application to FDA.86
Studies with devices of nonsignificant risk may not require an IDE, but must be approved by the IRB before the study can begin. The following key elements are inherent in all IDE studies:
• informed consent from all users,
• labeling for investigational use only,
• monitoring of the study, and,
• required records and reports.
An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would otherwise apply to devices in commercial distribution. Sponsors need not submit a PMA or Premarket Notification 510(k), register their establishment, or list the device while the device is under investigation. Sponsors of IDEs are also exempt from the Quality System (QS) Regulation except for the requirements for design control. Extensive record-keeping, reporting, and monitoring of the clinical studies is also required.