FDA has new approaches to navigating the complex regulatory landscape and systems in place to remove the burdens of securing marketing clearance for innovative devices that promise to improve patient care. Gaining an awareness of their availability and understanding ways that they can turn regulatory challenges into strategic opportunities are the first steps toward managing regulatory compliance without sacrificing the momentum of new product development. Engineers and regulatory affairs professionals who attend this session will walk away with new tools to leverage when they seek clearance on their next device.
