IDE Application - Required Elements

The following elements have to be included in the Investigational Device Exemption (IDE) application submitted to the FDA:

1. Name and address of sponsor
2. Report of prior investigations and it must include:


• a bibliography of all publications, whether adverse or supportive, that are relevant to an evaluation of the safety and effectiveness of the device
• copies of all published and unpublished adverse information
• copies of other significant publications if requested by an IRB or FDA
• a summary of all other unpublished information (whether adverse or supportive) that is relevant to an evaluation of the safety and effectiveness of the device
• if nonclinical laboratory data are provided, a statement that such studies have been conducted in compliance with the Good Laboratory Practice (GLP) regulation in 21 CFR Part 58. If the study was not conducted in compliance with the GLP regulation, include a brief statement of the reason for noncompliance.


3. Investigational plan including the following items in the following order:


• purpose (the name, intended use, the objectives and duration of the investigation)
• protocol (describe the methodology and demonstrate its scientific soundness)
• risk analysis (a description and analysis of all increased risks to the research subjects and how these risks will be minimized; a justification for the investigation; and a description of the patient population including the number, age, sex, and condition)
• description of this device (important component, ingredient, property, and principle of operation and any anticipated changes in the device during the investigation)
• monitoring procedures (the sponsor's written procedures for monitoring the investigation and the name and address of each monitor.
• additional records and reports (a description of any records or reports of the investigation other than those required in Subpart G of the IDE regulation).


4. A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and installation of the device
5. An example of the agreement to be signed by the investigators and a list of the names and addresses of all investigators.
6. 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
7. 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 (when available)
8. The name and address of any institution (other than those above) where a part of the investigation may be conducted
9. The amount, if any, charged for the device and an explanation of why sale does not constitute commercialization
10. Please note that an environmental assessment as required under 21 CFR 25.40 or a claim for categorical exclusion under 21 CFR 25.30 or 25.34 is no longer required.
11. Copies of all labeling for the device
12. Copies of all informed consent forms and all related information materials to be provided to subjects as required by 21 CFR 50, Protection of Human Subjects
13. Any other relevant information that FDA requests for review of the IDE application. Information previously submitted to FDA in accordance with Part 812 may be incorporated by reference.