FDA Regulatory 101: Medical Devices Regulations and FDA Approval

Are you a medical device entrepreneur struggling to navigate development and FDA regulations?

Without a solid FDA regulatory strategy, your product may never reach the market. In this essential seminar, you’ll learn the fundamentals of FDA regulations for medical devices, including device classification, approval pathways, and the strategic implications of each option. Walk away with a clearer understanding of how to position your device for approval and attract investor confidence.

You’ll begin to answer questions like:

• What class is my device?

• What regulatory requirements apply?

• What are the implications for time, cost, and risk?

Your Guide:

Jim Gustafson is a retired medical device executive. He has more than 30 years’ experience in Class II and III medical device regulatory strategy and clinical trials for new medical devices. He has received more than 75 510(k)s, PMAs, PMA supplements, IDE, and HDE approvals from FDA. He has managed more than 12 IDE and post-approval clinical trials that enrolled and followed more than 2,500 patients on three continents. He has had more than 15 face-to-face meetings with FDA, made 3 presentations to FDA Advisory Panels, and cleared 3 FDA Warning Letters. He helped his company win the 2010 Baldridge National Quality Award.