Learn from our experience to streamline your regulatory pathway and set your new medical device or technology up for commercialization success.
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 can then study 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.
GCMI proudly offers an introduction to IDE in a webinar on April 14, 2022 from 12:30 p.m. to 1:30 p.m. eastern. Attendees will learn from:
- Mike Fisher, Director of Product Development, GCMI
- Ted Heise, VP Regulatory and Clinical services, MED Institute (the newly independent CRO arm of Cook Medical)
- 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
- Karen Winsley, formerly a Program Manager at CR Bard, currently providing independent consulting services for medical technologies product development
What will attendees learn?
- What’s required by FDA to get into an IDE trial: Hint: robust design history files, and answers to questions that validate or confirm clinical hypotheses.
- What clinical trials need to answer in order for the greatest potential for regulatory approval. Hint: key players include regulatory associates, internal review boards, contract research associates and design history file team members.
- Clarity on pathway to regulatory approval in clinical use and broad patient populations.
Who should attend?
- Early stage medical device and technology companies
- Academic investigators
- Physician entrepreneurs
- Clinicians interested in participating in clinical studies
- Investors in new medical technologies who want to ensure capital efficient design, development and regulatory approval pathways for their invested companies