FDA guidances

Some false or misleading guidances on FDA's website.
By Bradley Merrill Thompson March 8, 2019
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS. As a pro bono project, together...
By Dave Muoio December 21, 2017
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...
By Jonah Comstock December 30, 2016
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...