Regulatory Strategy Based on Novel Pathways

Device and diagnostic companies map the path to market, usually seeking the fastest, least burdensome path to market.  Several regulatory pathways exist for medical devices – each with their own challenges and each can present opportunities for managing the life cycle of your product.  Please join our panelists as they discuss the development of a regulatory road map for your product and strategies companies use to mitigate regulatory risks.  The fastest path may not be the best long term path.  Companies have the opportunity to evaluate and use de novo, 510(k), DTC, or PMA (or a combination of these). Learn how these companies have considered and leverage different regulatory paths to enter the market.  We will discuss current industry trends regarding this  pathways, and discuss some of the key factors in determining which path is best for your product and organization.