Doesn’t every manufacturer dream of new product development occurring in concert with FDA’s real time accelerated submission process? Well, here’s your chance! This white paper is to clear up any confusion regarding navigation of the Breakthrough Devices Program. It will aid you in the determination of whether your medical device or device-led combination product may receive Breakthrough Device Designation status. Keep in mind that if achieved FDA expects the same level of commitment, so put your best foot forward and read on!