Preparing an FDA IDE application? Learn the required documents—from sponsor identification and prior investigations to protocols, IRB approvals, labeling, and consent materials—for a complete, compliant submission.
Once you’ve determined that an IDE is required, the next step is preparing a complete IDE application for FDA review. FDA does not provide a standardized form for IDE submissions; instead, sponsors must compile a dossier containing all information specified in the IDE regulations. According to 21 CFR 812.20, an IDE application must include a series of required elements to allow FDA to assess the trial’s merit and safety. Below is a checklist of the key documents and information you need in your IDE submission (for a significant risk device study):
Name and address of the sponsor (the company, institution, or investigator initiating the trial). The sponsor is responsible for the application and must be U.S.-located or have a U.S. agent.
A comprehensive report of all prior research and testing done on the device. This includes:
The detailed plan for the clinical investigation, as specified in 21 CFR 812.25. The plan should be organized into:
A description of the methods, facilities, and controls used for manufacturing the device and any related processes (packing, storage, installation). Essentially, how you ensure device quality and consistency for devices used in the trial.
A list of the names and addresses of all investigators who will conduct the study, along with copies of the investigator agreement that each will sign. The agreement typically includes the investigator’s CV, relevant experience, and commitments to abide by the study protocol and regulations. (Note: FDA requires specific investigator commitments per 21 CFR 812.43(c), such as adhering to the protocol and informed consent requirements.)
A list of all Institutional Review Boards (IRBs) that have been or will be asked to review the study, along with the status of each IRB’s approval. If some IRB approvals are pending at the time of submission, you include a statement that certification of IRB approval will be provided later. FDA will not let a site enroll until its IRB approval is on file.
The name and address of every clinical site or institution (if not obvious from the investigator list) where the investigation will be conducted.
If the device has been marketed in the U.S. or another country, or previously cleared/approved, that information should be noted (though this is usually more relevant for devices that had prior use – many IDE devices are entirely new). If the sponsor plans to charge for the device during the study, the IDE must list the amount to be charged and provide justification that this does not constitute commercialization of the device.
Not required. FDA has waived the requirement for an environmental assessment or categorical exclusion for device trials, so this element can be skipped (formerly required in older regs, but no longer).
Copies of all labeling for the investigational device. This includes the label that goes on the device or packaging indicating it is for investigational use, as well as any instructions for use or physician labeling needed for the study.
All informed consent forms and any patient information sheets or brochures to be given to subjects. FDA will review these to ensure they meet 21 CFR Part 50 requirements (e.g., including all required consent elements and no exculpatory language).
Any additional information FDA has specifically requested or that the sponsor deems relevant to the review of the IDE. For example, if there was a prior related IDE or FDA feedback from a Pre-Submission meeting, those can be cross-referenced or included. Prior submissions can be incorporated by reference to avoid duplication.
Having all these sections complete and well-organized is critical. FDA reviewers will check for each required element. Missing information or poorly supported sections are a common reason for IDE application deficiencies. In fact, FDA notes that the three most common problem areas in IDE submissions are: – Inadequate Report of Prior Investigations – e.g., incomplete data or missing adverse findings. – Inadequate Investigational Plan – unclear objectives, incomplete protocol details, or missing risk mitigations. – Inadequate Device Description or Manufacturing info – lack of detail on device design or how it’s made/tested for quality.
Sponsors should use the above as a quality control checklist before submission. It can be helpful to create an internal table of contents matching FDA’s required order and to do a self-audit against the list. FDA has even provided a Suggested Administrative Checklist for IDE applications which sponsors can use to ensure completeness.
In summary, compiling a thorough IDE application means providing FDA with everything needed to evaluate the trial’s risks and merits: who you are, what you’ve learned about the device so far, how you plan to study it in humans, and how you will protect participants. Including all required documents – and double-checking that each is clear and well-supported – will speed up FDA’s review and reduce the chance of a refusal or deficiency letter. In the next section, we discuss the step-by-step process to submit these materials to FDA and obtain the IDE approval.
