AN INTRODUCTION TO THE U.S. FDA’S INVESTIGATIONAL DEVICE EXEMPTION (IDE): A GCMI WEBINAR

Ted Heise, PhD, RAC, Vice President of Regulatory and Clinical Services, will be a panelist on this upcoming webinar.

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