Masterclass: FDA Breakthrough Designation: How Can DTx Companies Navigate it?

Getting regulatory clearance/approval for DTx can be challenging, and it requires a learning curve to define the best regulatory strategy for a specific solution. Beyond the regulatory pathways (like the 510k or the de novo), DTx companies can also join voluntary programs that may help make these therapies available as rapidly as possible. In this masterclass led by Tim Marjenin (Vice President of Neurology Regulatory Affairs at MCRA, and former Assistant Director at the FDA), we will focus on the FDA Breakthrough Designation and how DTx companies can successfully navigate it. In more detail, Tim will walk us through: