The Bleeding Edge, an Academy Award nominated Netflix documentary, examines the $400 billion medical device industry and the 510K process for bringing a medical device to market. It looks at how profit driven incentives can put patients at risk. Hear patients speak of their experiences with these devices.
This interactive program will start with an overview of device regulations before we view the film. This will be followed by a panel discussion and Q & A session lead by our panelists.
Upon completion of this Webcast, attendees should be able to describe:
FDA’s IDE and 510K processes for bringing a device to market.
How devices that have not been tested in humans are brought to market.
How some devices approved through the 510K process have put patients at risk.
Target Audience: All Clinical Research Professionals
5:30-5:40 Welcome and Chapter Meeting
5:40-6:00 Introduction to Device Regulations
6:00-7:40 Viewing of The Bleeding Edge
7:40-8:15 Panel Discussion/Q & A