Learn how to submit an Investigational Device Exemption (IDE) to FDA. This step-by-step guide covers preparation, eCopy creation, submission methods, IRB coordination, FDA acknowledgement, 30-day review, decision outcomes, and starting your clinical study.
Submitting an IDE application to the FDA involves several coordinated steps. This guide walks through the process from preparation to FDA’s acknowledgement and review. Following these steps meticulously will help ensure your IDE submission is smooth and timely:
Before you send anything to FDA, assemble all the required elements of the IDE as detailed in the previous checklist. Write a clear cover letter for the IDE as well (FDA provides a “Suggested Content for Cover Letter,” which includes identifying the submission as an IDE, device name, sponsor contact info, and references to any prior Q-Submissions or risk determinations). The cover letter is important for administrative processing. Make sure the person listed as the contact (and the official sponsor) is U.S.-based, as FDA requires the IDE sponsor to be in the United States. Double-check that your documents are in FDA’s preferred format (for example, FDA suggests a particular order and headings for easy review). Common pitfalls at this stage include submitting an application that is premature – i.e., missing key testing data or having an incomplete protocol. Ensure all content is final and complete to avoid FDA placing your submission on hold for additional information.
FDA now requires most IDE submissions to be in electronic format. A valid eCopy is basically a CD, DVD, or flash drive (or an electronic file upload) containing your IDE submission in PDF format, meeting FDA’s technical standards. Use the FDA’s eCopy guidance to properly format file folders and PDF bookmarks. Tip: The eCopy must include a signed cover letter and all attachments; ensure the PDFs are virus-free and labeled correctly. If anything is missing or the eCopy is not formatted right, FDA may refuse to accept the submission.
You have two main ways to send in the IDE: – Online via CDRH Portal: The FDA’s Customer Collaboration Portal allows for secure electronic submission uploads. Sponsors can upload the eCopy files directly. This is usually the fastest method and provides confirmation of receipt. – By Mail/Courier: You can mail the eCopy on physical media to the FDA’s Document Control Center (DCC) in Silver Spring, MD. The address (as of writing) is listed on FDA’s site[58]. If using a courier or hand delivery, follow any additional instructions (e.g., calling ahead for drop-off). There is no user fee for IDE submissions – they are exempt from FDA user fees, unlike some marketing submissions.
In parallel with submitting to FDA, you should be submitting your study protocol to the Institutional Review Boards at your study sites. FDA and IRB reviews can occur simultaneously; you do not have to wait for one to finish before starting the other. In fact, doing them in parallel is ideal, since both FDA IDE approval and IRB approval at each site are required before a significant risk study can start. For an NSR study (if you mistakenly submitted one to FDA or converted via FDA’s determination), IRB approval is the key requirement since FDA IDE approval wouldn’t be applicable. Either way, coordinate with your investigators to get IRB applications moving early. Tip: FDA will assign an IDE number and send you an acknowledgement (usually via email) once your submission is received and logged. You should include that IDE number in any subsequent communications, and you’ll need it when communicating with IRBs as well.
After FDA’s DCC receives your IDE application, they will typically email an acknowledgement letter with the assigned IDE number (format “GYYxxxx” where YY is the year). This usually happens within days of receipt. The clock for FDA review starts at receipt of a complete application. If your submission is incomplete (missing an element or eCopy errors), FDA may contact you to correct that before the review “clock” starts.
By law, FDA aims to review IDE applications within 30 days. Thirty days after FDA’s receipt of the IDE, one of a few things will happen:
FDA will send a formal IDE decision letter via email. If approved (or approved with conditions), the letter will confirm you may proceed after obtaining IRB approvals. It will list any “conditions” (e.g., minor protocol tweaks or additional data to submit). Address any conditions promptly—you typically have 45 days to respond to FDA on conditions, even though you might start the trial in the meantime. If disapproved, use the detailed feedback to improve your application; you may request a meeting with FDA to clarify issues if needed, or use the pre-sub process to discuss a path forward.
With FDA approval and IRB approvals in hand, you may initiate the clinical investigation. Ensure that all investigators have the IDE number and a copy of the FDA approval letter, as IRBs often require this. Also, at this point, shipping the investigational devices to sites can occur (they must bear the required investigational labeling).
Throughout the process, maintain organized records of all submissions and correspondence. FDA may ask questions during the review (though formal IDE review is quick, sometimes they reach out for clarification or additional info within that 30-day window). Responding rapidly to any FDA inquiries can keep the review on track.
Finally, remember that obtaining the IDE is just the start – next comes conducting the trial under compliance. The following sections will cover what to expect in FDA’s review outcomes and how to manage the IDE post-approval (monitoring, reporting, etc.).
