Beyond fielding an ever-increasing number of digital health clearances, the FDA had a full plate in 2017 as it sought to revise its regulatory processes for the shifting healthcare landscape. The beginning of the year saw a new administration take the reins, and with it the nomination and appointment of a new commissioner, Dr. Scott Gottlieb. By the year’s end, the new guard already had announced...
Over and above clearing a number of devices, the FDA had a busy year in 2016, passing a number of draft and final guidances related to digital health, having some notable conversations with vendors, and even turning down some devices whose FDA clearance was expected this year. We've rounded up the year's 510(k)'s in a separate article, but here's a rundown on some of the other actions the...
