What is an IDE?
An investigational device exemption (IDE) allows you to collect safety and effectiveness data from a clinical study using your medical device while it is still under development. It’s important to remember that a device that has not been cleared by FDA cannot be used in clinical studies - unless you apply for an IDE (or have an exemption - more on that later). An approved IDE allows you to distribute your medical device for the purposes of completing a planned clinical study only. You need an approved IDE before you start your clinical study.
How do I know if I need an IDE?
The main criterion for determining if your study needs an IDE or not is safety. Studies can be classified as either significant risk (SR) or non-significant risk (NSR). You are responsible for making the first determination if your device is SR or NSR. Fortunately, the FDA provides a set of criteria that define SR devices. For example, SR devices include implants, devices that support human life, or devices that are of “substantial importance” for treating disease. In general, SR devices present a potential for serious risk to the health and wellbeing of a patient. Additional information can be found in FDA’s guidance document for SR and NSR studies. It’s also important to note that the FDA is the final arbiter on whether or not a device is SR. You can ask the FDA to make a specific determination for your study as well.
What about the IRB?
We mentioned that you are responsible for making the first determination if your device is SR or NSR. If you determine that your device is NSR and does not pose a significant risk to patient safety, you can contact an Institutional Review Board (IRB). IRBs are groups that review and monitor research and are regulated by the FDA. If you determine your device is NSR, and the IRB agrees, you can begin your clinical study. If the IRB determines your device is SR, then you still need to apply for an IDE from the FDA.