IDE Application

A sponsor of a significant risk device study must submit a comprehensive Investigation Device Exemption (IDE) application to FDA. The submission of an IDE application does not require any preprinted forms; however, it must include certain required information.

The sponsor must show in the application that there is reason to believe that:

• the risks to human subjects from the suggested investigation are outweighed by the expected benefits to subjects and the significance of the information to be gained
• the investigation is scientifically sound
• there is reason to believe that the device as proposed for use will be effective.

Required Elements for IDE Application

The significant risk device investigation cannot be initiated by a sponsor till FDA and IRB approval are granted for IDE application. The IDE application must include the following required elements:

• Name and address of sponsor
• Comprehensive report of prior investigations including reports of all prior clinical, animal, and laboratory testing of the device. Specific contents of the report must include:
• a bibliography of all publications, whether adverse or supportive, that are applicable to an assessment of the device safety and effectiveness
• copies of all published and unpublished adverse information
• copies of other important publications if demanded by an IRB or FDA
• a summary of all other unpublished information (whether adverse or supportive) that is applicable to an assessment of the device safety and effectiveness
• if nonclinical laboratory data are provided, a statement that such studies have been led in compliance with the GLP regulations in 21 CFR Part 58. If the study was not conducted in compliance with the GLP regulations, include a brief statement of the reason for noncompliance.
• Investigational plan comprising purpose of the investigation; protocol detailing the methodology to be used; risk analysis and how these risks will be minimized; detailed description of the investigational device; monitoring procedures; and description of additional records and reports.
• A explanation of the procedures and methods, facilities, and controls used for the manufacture, processing, handling, packing, storage, and installation of the device
• An example of the agreement/contract to be signed by the investigators and a list of the names and addresses of all investigators. Information that must be contained in the written agreement are found in § 812.43
• Certification that the agreement is signed by all investigators
• A list of the names, addresses, and chairpersons of institutional review board (IRB) that have or will be asked to evaluate the investigation and a certification of IRB action concerning the investigation (when available)
• 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 as required by 21 CFR 50, Protection of Human Subjects
• Any other relevant information that FDA requests for review of the IDE application.

Common Problems with Original IDE Applications

The following are the three common areas that are frequently deficient in IDE applications:

• Inadequate report of prior investigations
• Inadequate investigational plan
• Inadequate/incomplete design and manufacture

Sponsors of a significant risk device investigation must submit three copies of a signed IDE application.

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