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.

Join GCMI Director of Product Development Mike Fisher, Ted Heise, VP Regulatory and Clinical services, MED Institute, Janet Krevolin, PhD, Chief Operating Officer for Novum Medical and Professor of the Practice, Biomedical Engineering, Tufts University and Karen Winsley, independent consultant for medical technologies product development on April 14, 2022, at 12:30 p.m. EDST as they walk through the following:

• 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.