Investigational Device Exemptions are required by the U.S. FDA for devices or technologies that require clinical use before regulatory approval or general market release. Examples of devices that may require an IDE study are first in human devices, devices that require Class III premarket approvals, some Class II devices, or a de novo device or technology that requires human use data to meet regulatory requirements.
At its essence, the IDE process allows a limited product release to enable the clinical use of a new device. The IDE trial studies a device’s safety, efficacy, and usability when there are too many unknowns for a general market release. The market release is constrained for use as prescribed in the clinical trial protocol and limited in distribution in approved institutions. All this is intended to mitigate the risk when studying a novel technology. The IDE is a common, critical activity and waypoint in the path to FDA full market approval.
On Thursday, April 14, four seasoned medtech experts shared their knowledge and insights on IDEs and clinical trial preparedness.
“[Despite your best plans,] you are always going to find surprises [in your regulatory and development pathway]. Double the amount of time it’s going to take, for an IDE I might say triple the time at this point [and likely triple the money needed]. Have contingency plans.” – Janet Krevolin, PhD, a former product development executive with Zimmer, is now Chief Operating Officer for Novum Medical and Professor of the Practice, Biomedical Engineering, Tufts University
“[In planning [a clinical trial], have a package of evidence to support its expectation of reasonable safety when it’s used in humans, including extensive non-clinical or preclinical data. Think ahead. What types of claims do you want to make? That drives the regulatory requirements, which in turn drives the need for clinical data and what that data should look like.” – Ted Heise, VP Regulatory and Clinical services, MED Institute (the newly independent CRO arm of Cook Medical)
“If it wasn’t documented, it didn’t happen. Your risk mitigation process is an ongoing process. The reasons behind corresponding evaluation of the effect of any changes would be the trigger that the FDA or someone evaluating an IDE would be looking for.” – Karen Winsley, formerly a Program Manager at CR Bard, currently providing independent consulting services for medical technologies product development on the importance of design history files [DHF] for new medical technologies.
“A DHF is like building a foundation for a larger building. The most disruptive pivot is if you get the user need wrong, and the entire foundation shifts. The clinical trial [as required in an IDE submission actually becomes] an element of your DHF.” – Mike Fisher, Director of Product Development, GCMI
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