IDE permits the investigational device to be used in a clinical study in order to assemble data related to safety and efficacy. In order to support PMA clinical studies are conducted whereas as in the case of 510(k)s rarely clinical data is needed for the application. Clinical evaluation of specific modifications or new intended use of legally marketed devices is to be incorporated for investigational use. Before the clinical study is initiated all the possible clinical evaluations of investigational devices, unless exempt, must have an approved IDE. Perhaps, IDE is considered mandatory for devices that are unable to get marketing clearance using 510(k) notification and PMA applications.
The following are requirements to proceed with IDE.
- An approved IRB investigational plan
- Informed consent from all patients;
- Labelling stating – The device is for investigational use only;
- Evaluation of the study and;
- Records and reports.
Complete IDE application must be submitted by the manufacturer to FDA. Despite, it does not have a pre-determined format, but they are confined to include precise information in the form, such as sponsor investigator information, clinical plan overview and investigational plan method and controls information.