Current Insights into the FDA Premarket Landscape

Our session will delve into the current FDA premarket landscape by highlighting key CDRH initiatives and programs, new guidance documents, and updates to the CDRH workforce. We will present varying perspectives on some of the programs that have garnered industry and FDA attention, such as the Breakthrough Devices and Safer Technologies programs, in addition to the widely used Q-Submission program. Our session will include case studies to illustrate how effective communication from both FDA and industry can achieve faster access to medical technologies in the US.