Unexpected issues are pretty much a guarantee in life. As regulatory folks (maybe a bit type A), we like to plan and prepare as much as we can, so the unexpected hiccups are much easier to deal with. When you’re submitting an Investigational Device Exemption (IDE) to the FDA, you should know a few basics to help things run more smoothly.
Let’s review what information is needed in an IDE submission, what decisions you can expect from the FDA, and the typical timeline for an IDE study.
What Is Included in an IDE Submission to FDA?
When you submit an IDE, you’ll need to include the following information to make it complete. That is, make sure you have all your ducks in a row before you dive in. Here is what you need, as outlined in 21 CFR 820.20:
- Name and address of sponsor
- Report of prior investigations and investigational plan (Details in 21 CFR 812.25 and 812.27)
- Description of manufacturing, processing, packing, and storage of device
- An example of the investigator agreement and list of investigators who have signed agreement
- Certification that all investigators who participate in the investigation will sign the agreement
- List of the name, address, and chairperson of each IRB
- Participating institutions
- If the device is to be sold, the amount to be charged, and an explanation
- Environmental assessment or exclusion
- Subject materials including informed consent
- Additional information requested by FDA
Possible FDA Decisions
What are the possible decisions that FDA can make? Within 30 days of receipt of the IDE submission, FDA will make one of the following decisions, as taken from IDE basics:
Hooray! This means the FDA approved the trial for a “specified number of sites and subjects” and you can begin enrolling subjects once IRB approval is obtained.
2. Approval with conditions
This is just as it sounds – you have approval, but you need to address a few things first. The FDA “approves the trial for specified number of sites and subjects provided conditions (deficiencies) are addressed within 45 days,” and, again, IRB approval must be obtained before you can begin enrolling subjects.
Obviously, you cannot begin your study if you receive this decision. You have to first address deficiencies and obtain approval before you can start.
The disapproval decisions is “based on concerns related to subject safety and protections.” It’s important to note that “an IDE cannot be disapproved on the basis of FDA’s belief that the study design is inadequate to support a future PMA, 510(k), humanitarian device exemption (HDE), or de novo classification.”
Other Elements of FDA Decision Letters
When you receive a decision letter, there may also be two other considerations:
Study design considerations
In this case, the FDA will provide recommendations (but not requirements) regarding the study design to help the study achieve its goals. This can provide helpful insight to keep in mind as you move forward to give you the best chance for success.
The FDA may point out issues relevant for future submissions (e.g. future marketing application), and this can help you plan for the next step in your process.
Note: Sponsors are not required to respond to study design considerations and future considerations
Typical Next Steps for an IDE Study Sponsor
Before you can begin your trial, you should generally request a pre-sub meeting with the FDA as you finalize the device and study design. Then, following that interaction, you submit your original Investigational Device Exemption (IDE) Submission to FDA.
And, if required, you will have to submit Amendments to address concerns raised by FDA about the Original IDE. Once you have FDA approval, the typical next steps would be:
- Enroll Sites and Initiate Study
- Submit any Supplements and 6-month/Annual Reports
- Supplements (812.35) for: Change in protocol; Change in device
- Reports (812.150) for: Annual progress; Unanticipated adverse device effects; Follow-up completion; Current list of investigators; Final report (see below)
3. Marketing Submission to FDA
4. Final IDE Report (within 3 months after termination or completion of the investigation)
We hope that this helps you get a better understanding of some aspects of an IDE submission. As always, Mr. Regulatory is here to help answer any of your more detailed or specific questions.
For further information, reference: