Health IT Safety Center

By Jonah Comstock 11:19 am April 4, 2014
The FDA, along with the FCC and ONC has finally released the report to Congress required by the FDA Safety and Innovation Act (FDASIA) of 2012. This FDASIA report, called "Proposed Strategy and Recommendations for a Risk-Based Framework," reiterates previously articulated FDA positions on regulatory discretion and avoiding regulatory redundancy between the FDA, ONC, and FDA. It's based on the...