Examining CDRH, Device Innovation & Agency Communication

On this episode

About this episode

Wayne chats with Sandra Cohen Kalter, member of the Strategic Advisory Group for iTolerance and a retired legal regulatory attorney from industry, and Steve Silverman, President of the consultancy The Silverman Group . You'll hear their thoughts on how CDRH has been affected over the past year, whether the center has the resources and cross-agency collaboration it needs to fulfill its regulatory mandate, FDA's capacity to support innovation amid review pressure and staffing cuts, how companies can find reliable up-to-date regulatory information that's not available through FDA communications avenues, FDA's ability to monitor safety and performance throughout a device's life cycle, and much…