- October 31, 2022 -The number of breakthrough device designations issued by the Food and Drug Administration fell in the third quarter.? At the midpoint of the year, the FDA ha issued 129 designations, putting it on track to beat the record of 206 that it set in 2021. However, the rate of new breakthrough designations slowed to 35 in the third quarter. The designation gives devices expedited review if they meet certain criteria, including treating or diagnosing?life-threatening conditions, and providing a device where no cleared or approved alternatives exist.?The FDA is considering changes to its criteria to include technologies that address health disparities.?Please click here to read the full article!
