FDASIA

FDA reneged on its promise to take a risk-based approach to CDS software
By Bradley Merrill Thompson | 02:23 pm | April 11, 2018
At congressional hearing, FDA's Shuren talks digital health, patient engagement, real-world evidence
By Jonah Comstock | 03:51 pm | March 31, 2017
Not much new in FDASIA report, Congress still champing at the bit
By Jonah Comstock | 12:19 pm | April 04, 2014
How the FDA can improve regulation of mobile health, according to FDASIA workgroup
By MHN Staff | 08:07 am | March 03, 2014
Analysis: 103 FDA regulated mobile medical apps
By Brian Dolan | 05:25 am | November 26, 2013
In tense hearing, congressman declares "software is not a medical device"
By Brian Dolan | 06:18 am | November 21, 2013
Part 2: Set FDA's mobile medical app guidance free
By MHN Staff | 01:15 pm | September 04, 2013
Mobile health oversight: Stability will come with clarity, not rush
By MHN Staff | 12:59 pm | September 04, 2013
Final days of waiting for FDA mobile medical app guidance?
By Brian Dolan | 06:40 am | June 25, 2013
HHS workgroup could shape mHealth regulation
By Jonah Comstock | 08:48 am | April 19, 2013