FDA Office of Patient Affairs

By Heather Mack March 31, 2017
In the first quarter of 2017, we tracked seven digital health-related FDA clearances. While the list isn’t long, it’s varied and relatively novel – from app and device integrations for diabetes treatment to a vest that maps cardiac rhythms. The beginning of this year also rang in some big changes, as the Trump Administration took root and nominated Dr. Scott Gottlieb as FDA deputy commissioner....
By Jonah Comstock March 15, 2017
The FDA is considering the creation of an Office of Patient Affairs, focused on soliciting the perspectives of patients and taking those insights into account as it sets regulatory policy. The move grows out of a provision in the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law by President Obama in 2012. FDASIA instructs the HHS secretary to  "develop and...