Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices by RAQA Today published on 2022-08-09T13:24:28Z You've developed a novel technology and want to bring it to market in the US. Now what? Can you submit as a breakthrough device, or is the de novo route a better choice? How are they different? How are they similar? Breathe - and listen in as Michelle walks you through the options.