FDA Breakthrough Devices Program
Since the Innovation Pathway program initiated in 2011, the Food and Drug Administration (FDA) has provided means to expedite its review process for groundbreaking products. While critics question how faster review cycles impact patient safety, one thing is clear…products approved under priority review suffer more quality issues.
More on that later. The latest incarnation of a priority review track is the Breakthrough Devices Program, the spiritual successor to the Expedited Access Pathway...