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 there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects and the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective – The U.S. Food & Drug Administration (FDA).
Several required elements must be included in an IDE application such as:
- A report of prior investigations – containing at least a bibliography of all publication, copies of all published and unpublished adverse information, copies of other significant publications if requested by an Institutional Review Board (IRB) or FDA, a summary of all other unpublished information, if nonclinical laboratory data are provided, a statement that such studies have been conducted in compliance with the Good Laboratory Practice (GLP) regulations or a rational if not.
- An investigational plan (21 CFR 812.25) – including at least the purpose of the investigation, a protocol, a risk analysis, a justification for the investigation; a description of the patient population, a description of the device, the monitoring procedures and additional records and reports. The investigational plan must be approved by each participating study site’s IRB.
- A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and installation of the device.
- An example of the agreement to be signed by the investigators and a list of the names and addresses of all investigator.
- Certification that all investigators have signed the agreement, that the list of investigators includes all investigators participating in the study, and that new investigators will sign the agreement before being added to the study.
- A list of the names, addresses, and chairpersons of all IRBs that have or will be asked to review the investigation and a certification of IRB action concerning the investigation.
- The name and address of any institution (other than those above) where a part of the investigation may be conducted
- The amount, if any, charged for the device and an explanation of why sale does not constitute commercialization
- Copies of all labeling for the device.
- Copies of all informed consent forms and all related information materials to be provided to subjects.
- Any other relevant information that FDA requests for review of the IDE application.
The required content of an IDE is provided in 21 CFR 812.20, including the specific order in which the information should be presented. FDA is, however, somewhat liberal on sequence, as long as all the information is included and presented in a logical fashion.
As a reminder, a clinical study performed in the U.S. must have a U.S. sponsor (A clinical study sponsor is a person, company, institution, group, or organization that oversees or pays for a clinical investigation and collects and analyzes the data). Therefore, a foreign manufacturer must have a U.S. entity submit the IDE.