Opportunities for companies to engage with FDA during the development  and review of new devices have grown over the years. And if Jeff Shuren,  Director of the agency’s Center for Devices and Radiological Health,  has his way, there will be even more fundamental change in the years to  come.   

In this conversation, Shuren talks about the evolution of FDA-sponsor  interactions that has occurred over his tenure, the “real-time”  engagements during COVID-19, and CDRH’s proposal for a TPLC Advisory  Program (TAP), which Shuren says will be a game-changer, allowing  companies unprecedented access to FDA, payors, providers, and others  along the development route.   

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