Making the decision as to what designation you’ll run your clinical study under is an important one. If you’re thinking about conducting a clinical study under an Investigational Device Exemption (IDE), here are a few things to consider.

Visit FDA’s CDRH Learn

It’s a bit daunting, but the FDA has a huge amount of resources available on CDRH Learn. Start with IDE Basics. Then, check out the details about FDA’s Early Feasibility Study (EFS) and Breakthrough Devices Programs.

If your device is not eligible for a Breakthrough Device Designation because it is not intended for the treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition, consider whether or not it would be a candidate for the Safer Technologies Program (STeP). (More on those in a later post.)
Note: Jon Speer, Founder of Greenlight Guru, and I discussed IDE in this podcast. He’s fantastic. Check it out.

Is Your Device Exempt ?

Determining whether or not your clinical study is exempt from IDE designation can be found in the “IDE Basics”document. In this document, the FDA includes this helpful diagram to understand when a product requires an IDE:

The FDA considers exempt studies that do not need an IDE to be those involving: “commercial devices used in accordance with labeling,” certain diagnostic devices, consumer preference testing of a modification or combination of devices (not involving safety or effectiveness or putting subjects at risk), “veterinary devices or research on/with laboratory animals,” and “custom devices as defined in 812.3(b).”

Those studies that are considered “non-significant risk” do not require an IDE submission either. These can be studies with “abbreviated requirements (labeling, IRB, consent, monitoring, reporting, prohibition on promotion).” The “IRB serves as the FDA’s surrogate for review, approval, and continuing review of the NSR device studies.” FDA further states that in such a case, “an NSR device study may start at the institution as soon as the IRB reviews and approves the study.”

Does your device fall into these categories? If not, your clinical study may fall into the non-exempt studies category.

Non-Exempt Studies: You Need to File an IDE

These studies cannot begin until the IDE is approved by the FDA because they pose a potential risk to the subject. These can include, “an implant; or used in supporting or sustaining human life; or of substantial importance in diagnosing, curing, mitigating, or treating disease or preventing impairment of human health; or otherwise poses a risk.”

Once you’ve made it this far, it’s time to decide what to include in an IDE Submission. This will vary, but it’s always a good idea to think about how you will market your device once it’s ready for that stage. As always, feel free to contact us with any questions.


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